MedX = Corporation, Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	555 Winderley Place, Suite 200 Maitland, FL 32751=20

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-08-09

February 4, 2008

David V. Dettmers, President/CEO
MedX Corporation, Corporate=20 Headquarters
285 West Central Parkway, Suite 1726
Altamonte = Springs, FL=20 32714

Dear Mr. Dettmers:

During an inspection of your firm located at 1401 Northeast 77th = Street,=20 Ocala, FL 34479, on August 8, 9, 13, 14, 15, and 16, 2007, an = investigator from=20 the United States Food and Drug Administration (FDA) determined that = your firm=20 manufactures measuring exercise equipment and isokinetic testing and = evaluation=20 systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic = Act (the=20 Act), 21 U.S.C. 321(h), these products are devices because they are = intended for=20 use in the diagnosis of disease or other conditions or in the cure, = mitigation,=20 treatment, or prevention of disease, or are intended to affect the = structure or=20 function of the body.

Our inspection revealed that the lumbar (K880032) and cervical = extension=20 (K896533) devices are adulterated within the meaning of section 501(h) = of the=20 Act, 21 U.S.C. =A7 351(h), in that the methods used in, or the = facilities or=20 controls used for, their manufacture, packing, storage, or installation = are not=20 in conformity with the Current Good Manufacturing Practice (CGMP) = requirements=20 of the Quality System Regulation (QSR), Title 21, Code of Federal = Regulations,=20 Part 820 (21 CFR 820). We received two (2) response letters from your = firm=20 concerning our investigator's observations noted on the Form FDA 483,=20 Inspectional Observations (FDA 483), issued to your firm at the close of = the=20 inspection. The first response letter was dated August 31, 2007; signed = by David=20 Fleming, Chief Financial Officer; and was received by the Florida = District=20 Office via facsimile on August 31, 2007. In the letter your firm = requested=20 additional time to formulate a response. The second response letter was = also=20 dated August 31, 2007; also signed by David Fleming, now Chief Operating = Officer; and was received by the Florida District Office on September = 11, 2007.=20

This response letter contained a detailed list of your firm's = intended or=20 accomplished corrective actions to each of the twelve (12) FDA 483 = observations.=20 We address your firm's responses below in relation to each of the noted=20 violations. These violations include, but are not limited to, the = following:=20

1. Failure to adequately establish and maintain procedures for = software=20 validation and to perform risk analysis, where appropriate, as required = by 21=20 CFR 820.30(g). For example:

a. Design validation of device software was not performed for some = versions=20 of the software and is inadequate for other versions. Specifically, = your firm=20 has not conducted validation of your [redacted] Software after changes = to the=20 software's functionality have been made from your first distribution = of=20 Version [redacted] through your current Version [redacted]. Also your = firm's=20 most current software validation of the [redacted] Software [redacted] = Platform is inadequate in that the validation that was conducted for = Version=20 [redacted] consisted primarily of functional testing (black-box = testing) and=20 lacks other elements of software validation including structural = testing=20 (white-box testing).

b. Risk analysis of the [redacted] Software does not include risk=20 associated with your Lumbar Extension (LU53) and Cervical Extension = (NE51)=20 devices operated in conjunction with the [redacted] Software as a = system.=20

We have reviewed your response dated August 31, 2007. Your firm has = been=20 notified of software validation violations on numerous occasions in the = past=20 beginning with a FDA 483 issued to your firm on February 21, 1995. As a = result=20 of the subsequent inspection on March 24,and 25, 1998, Warning Letter = FLA-98-46=20 dated April 20, 1998, was issued to your firm in part addressing your = firm's=20 failure to validate changes to components (such as software). = Notification of=20 this and/or similar violations were also provided to your firm in a FDA = 483=20 issued to your firm on March 30, 2000. Software validation was again = discussed=20 with your firm during our September 30 through October 2, 2002, = inspection. This=20 violation was yet again observed during an inspection of your firm on = July=20 24-27, 2006, to which your firm again promised correction by stating to = one of=20 our investigators and an Accredited Person (AP) that the firm would = conduct both=20 structural and functional testing if a major rewrite of the source code = was=20 implemented. In addition, your firm failed to include risk analysis in = the=20 design plans for the [redacted] software project. It was also brought to = your=20 firm's attention by one of our investigators and an Accredited Person = (AP)=20 during an inspection of your firm on July 24-27, 2006. Your firm = promised=20 correction of the observation at that time, as well. In your response = dated=20 August 31 2007, you state detailed software and hardware specifications = for the=20 [redacted] software and associated machines (Lumbar and Cervical) as = well as=20 detailed software verification and validation plans are being developed. = You=20 also state that you have implemented a more robust hazards assessment, = failure=20 modes effects analysis and that all previous MDRs and complaint history = will be=20 incorporated into the risk assessment. In addition, you state in your = response=20 that employee training will also be provided for risk analysis. Since = your firm=20 did not provide the software specifications and software verification = and=20 validation plan, risk analysis, and documentation showing that personnel = had=20 been adequately trained on the risk analysis, the adequacy of the = response=20 cannot be determined at this time.

2. Failure to adequately establish and maintain design input = procedures that=20 address incomplete, ambiguous, or conflicting requirements, as required = by 21=20 CFR 820.30(c). For example, your firm's design of the [redacted] = Software used=20 in the operation of your Lumbar Extension (LU53) and Cervical Extension = (NE51)=20 devices, includes the following ambiguous input requirements:

a. "Where possible, duplicate keystrokes in order to minimize = training=20 curve for operators", does not identify which keystrokes are able to = be=20 duplicated. Furthermore, design validation revealed the [redacted] key = was=20 duplicated, but its functionality was changed not allowing the "Fill" = unction=20 to be used with graph analysis.

b. "Ability to select test =95 ROM =95 Isometric/Static =95 = Dynamic," does not=20 identify all possible methods to select the tests including Function = Key,=20 Icon, or Menu Item.

We have reviewed your response dated August 31, 2007. In your = response, you=20 state detailed software and hardware specifications for the [redacted] = software=20 and associated machines (Lumbar and Cervical) as well as detailed so are = verification and validation plans are being developed. Since you have = not=20 provided the software specifications and software verification and = validation=20 plan the adequacy of the response cannot be determined at this time. =

3. Failure to adequately establish and maintain procedures to ensure = design=20 verification confirms that the design output meets the design input=20 requirements, as required by 21 CFR 820.30(f). For example, your firm = failed to=20 establish the design input requirements for the design output chart = "Lumbar=20 Extension Dynamic Test, Torque in Ft.-Lbs. vs. Degrees," a chart used to = determine the correct operation of the Lumbar Extension (LU53) device = for final=20 release. Accordingly, design verification of the [redacted] Software did = not=20 confirm that the design output meets the design input requirements.

We have reviewed your response dated August 31, 2007. In your = response, you=20 state that your firm has released a "Quality Control test" as part of = its=20 software that corrects this deviation and provided us with sample = graphs.=20 However, as was recognized in your firm's response, this correction = cannot be=20 confirmed without test data which your firm stated it would gather the = next time=20 it manufactured a Lumbar Extension unit. During the current inspection, = our=20 investigator observed several Lumbar Extension units at your firm; = therefore, we=20 find it unacceptable to delay your testing until such time as your firm=20 manufactures additional units. Furthermore, we find it prudent and = necessary for=20 your firm to include in its testing all Lumbar Extension units currently = in your=20 inventory to verify that the design output meets the design input = requirements=20 for those devices prior to their release.

4. Failure to adequately validate computer software for its intended = use=20 according to an established protocol, as required by 21 CFR 820.70(i). = For=20 example, the validation for the Computer Numerical Control machines was = not=20 performed.

5. Failure to adequately validate with a high degree of assurance and = approve=20 according to established procedures a process whose results cannot be = fully=20 verified by subsequent inspection and test, as required by 21 CFR = 820.75(a). For=20 example, your firm failed to adequately validate the manufacturing = process of=20 welding. Your firm's welding process is outlined in, your "Test Protocol = Production Welding Procedure Qualification" emphasizing personnel = qualification=20 to perform seven weld methods/types which include elements of = Performance=20 Qualification (PQ), but does not address all elements of process = validation=20 including Installation Qualification (IQ) and Operational Qualification = (OQ).=20

We have reviewed your response dated August 31, 2007. In your = response, only=20 blank example process validation forms are included. Also, there is no=20 Engineering Change Number ("ECN#") for procedure QAP/1200 indicating = that the=20 design changes are only proposed and have not been accepted for = implementation.=20 We are concerned that QAP/ 1200 may have been "released into the system" = without=20 adequate IQ and OQ validation procedures. Until such time that you = provide=20 documentation of procedural acceptance for QAP/1200 and IQ and OQ = validation=20 procedures, we cannot consider your response to this observation = adequate.

6. Failure to adequately establish and maintain procedures to ensure = that all=20 purchased or otherwise received product and services conform to = specified=20 requirements, as required by 21 CFR 820.50. For example, your firm has = not=20 conducted and documented evaluation of your current suppliers of = electronic=20 products including [redacted] and [redacted] used in the manufacture of = your=20 Lumbar Extension (LU53) and Cervical Extension (NE51) devices, in = accordance=20 with your procedure PUR/0200, Rev. 2, Vendor Assessment Procedure. = Furthermore,=20 your procedure does not define the type and extent of control to be = exercised=20 over these suppliers, the electronic products, and also consultants = including=20 your current Director of Quality/Quality Management Representative.

We have reviewed your response to this observation dated August 31, = 2007, in=20 which you promised correction of this observation by October 12, 2007. = Your firm=20 failed to provide FDA with copies of the following records referenced in = your=20 response as evidence of your proposed "[f]ormal qualification of all = critical=20 suppliers": your firm's list of critical suppliers; a revised PUR/0200, = Vendor=20 As Procedure; and supplier survey forms. Therefore, your response is = inadequate=20 until such time as all your suppliers have been assessed and the = appropriate=20 type and extent of control has been applied and determined to be = adequate.

7. Failure to adequately establish and maintain procedures to ensure=20 appropriate sources of quality data are analyzed to identify existing = and=20 potential causes of nonconforming product, as required by 21 CFR = 820.100(a)(1).=20 For example, your procedure QAP/0600, Rev. 5, Action Requests does not = include=20 provisions for analyzing appropriate sources of quality data (e.g., = analyzing=20 processes, work operations, concessions, quality audit reports, quality = records,=20 service records, complaints, and returned product) to identify existing = and=20 potential causes of nonconforming product and other quality problems. =

We have reviewed your response to this observation dated August 31, = 2007, in=20 which you provided a copy of QAP/0600, Rev. 6, as evidence of = correction. We=20 find your response adequate as stated in your newly revised = QAP/0600/5.1.1:=20 "Processes, work instructions, nonconformances (particularly "use as = is"),=20 internal and external audits, quality records, service (repair and = Driver's=20 notes), complaints, returned goods and other sources of quality data to = identify=20 existing and potential causes of nonconforming products, or other = quality=20 problems should be considered when generating AR's."

8. Failure to adequately establish and maintain procedures for = acceptance or=20 rejection of finished device production runs, lots, or batches and to = document=20 the necessary signatures for these acceptance activities, as required by = 21 CFR=20 820.80(d). For example:

a. Your firm failed to adequately implement your procedure = QCP/0200/004A,=20 Rev. 2, Final Test Procedure for Lumbar Extension Machine (with = Sections 4.4.8=20 and 4.4.9 of the procedure state to use Lumbar Friction Acceptable = Limits=20 Overlay (QCP/0200/004A-1) and if the comparison to the Dynamic Test = result=20 graph indicates friction outside the acceptable limits, then repeat = test.=20 Device history records for Lumbar Extension (LU53) including S/N = 01531240, S/N=20 01531234, and S/N 0122997 reveal out-of-specification results for the=20 [redacted] testing level and no retest.

b. Your firm did not = sign and=20 date the Extension Final Quality Check List, S/N 01531240 and Cervical = Extension Final Quality Check List, S/N 02511145 was also not signed = and=20 dated.

We have reviewed your response dated August 31, 2007. In your = response, your=20 firm states that it has released a "Quality Control test" as part of its = software that corrects this deviation and provided us with sample graphs = displaying the sample limits. However, as was recognized in your firm's=20 response, this correction cannot be confirmed without test data. During = the=20 current inspection, our investigator observed several Lumbar Extension = units at=20 your firm; therefore, we find it unacceptable to delay your testing = until such=20 time as your firm manufactures additional units. We find it prudent and=20 necessary for your firm to include in its testing all Lumbar Extension = units=20 currently in your inventory to verify that the design output meets the = design=20 input requirements for those devices prior to their release.

9. Failure to adequately investigate complaints involving the = possible=20 failure of a device to meet any of its specifications, as required by 21 = CFR=20 820.198(c). For example, your firm failed to document investigations = into=20 complaints involving the failure of USB Interface (USB Upgrade Box) = including=20 Complaint #105 (Received 03/23/2006), Complaint #106 (Received = 04/10/2006),=20 Complaint #107 (Received 04/10/2006), Complaint #197 (Received = 06/07/2006), and=20 Complaint #206 (Received 06/14/2007). Your firm replaced only those = affected=20 products associated with the above mentioned complaints. Your firm also = failed=20 to document any follow-up to the above mentioned complaints.

We have reviewed your response to this observation dated August 31, = 2007. In=20 your response, your firm promised to develop and implement qualification = procedures for all "critical suppliers' those having direct impact on = fit, form=20 or function of MedX products (e.g., [redacted] and [redacted]) by = October 12,=20 2007. However, since no documentation regarding follow-up investigations = into=20 the aforementioned complaints was provided in your response letter, the = adequacy=20 of your response cannot be determined at this time.

10. Failure to adequately establish and maintain document control = procedures=20 that ensure adequacy and, approval prior to issuance, as required by 21 = CFR=20 820.40(a). For example, production record for the Lumbar Extension = (LU53) device=20 contains standard work instruction document 'SWI/0100/P001-1 Rev. 5' = labeled=20 'Draft'. This is an unapproved document in use for manufacturing = operations.=20

11. Failure to adequately establish and maintain calibration = procedures that=20 ensure calibration standards are traceable to national or international=20 standards or other independent reproducible standards, as required by 21 = CFR=20 820.72(b). For example, record entitled, 'MedX=AE Weight Stack = Certification'=20 contained within Device History Record for the Lumbar Extension (LU53) = devices=20 including S/N 01531240 and S/N 01531234 and the Cervical Extension = (NE51)=20 devices including S/N 02511141 and S/N 02511145 were calibrated using=20 instruments that are certified with reference to Calibration #571996. = There was=20 no data to support that reference #571996 is traceable to a national,=20 international, or other independent reproducible standard.

12. Failure to adequately establish and maintain procedures for = quality=20 audits to assure that the quality system is in compliance with the = established=20 quality system requirements, as required by 21 CFR 820.22. For example, = your=20 procedure for conducting quality audits, QAP/0200, Rev. 8, Internal = Quality=20 Audits does not include quality management system requirements for = Medical=20 Device Reporting and Corrections and Removals to be audited.

We have reviewed your response to this observation dated August 31, = 2007, in=20 which you provided a copy of QAP/0200/1, Rev. 4, as evidence of = correction. Your=20 newly revised audit procedure QAP/0200-1/8.5.2, specifically states, "to = specifically assess MDR reporting and Corrections and Removals." We find = your=20 response to be inadequate until such time as you have implemented the = revised=20 QAP and assessed, in your internal or quality audit, MDR and Corrections = and=20 Removals. This action should take place immediately.

Our inspection also revealed that your lumbar and cervical extension = devices=20 are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), = in that=20 your firm failed or refused to furnish material or information = respecting the=20 device that is required by or under section 519 of the Act, 21 U.S.C. = 360i, and=20 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant = deviations include, but are not limited to, the following:

1. Failure to submit an MDR report within 30 days of receiving or = otherwise=20 becoming aware of information that reasonably suggest that a marketed = device may=20 have caused or contributed to a death or serious injury, as required by = 21 CFR=20 803.50(a)(1). For example, your firm failed to submit MDR = #1051095-2005-00001=20 (Aware Date: 05/06/2004, Reported Date: 12/23/2005) within 30 days of = receiving=20 or otherwise becoming aware of information that reasonably suggests that = a=20 marketed device may have caused or contributed to a death or serious = injury, in=20 accordance with the procedure FDA/0600, Rev, Vendor Assessment = Procedure.

We have reviewed your response dated August 31, 2007. Your firm = agrees that=20 the company did not report within, the regulated 30-day requirement. A = training=20 session was held with the MedX team on August 29, 2007, to reinforce the = clock=20 requirements for the MDR reportable events. In addition, an MDR internal = audit=20 was scheduled for September 4 and 5, 2007, to specifically determine if = any=20 further supplemental reporting to FDA needs to occur relative to all = past MDRs.=20 Your firm did not provide documentation showing that personnel had been=20 adequately trained on the MDR procedures. In addition, your firm did not = provide=20 documentation showing that an MDR internal audit was performed. The = adequacy of=20 the response cannot be determined at this time.

2. Failure to investigate and evaluate the cause of MDR Report, as = required=20 by 21 CFR 803.50(b)(3). For example, your firm failed to investigate and = follow-up on the outcome of the patient associated with MDR = #1051095-2061-00001=20 (the only information they relayed was "injured back") on the MedWatch = 3500A.=20

Our inspection also revealed that your lumbar and cervical extension = devices=20 are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), = in that=20 your firm failed or refused to furnish material or information = respecting the=20 device that is required by or under section 519 of the Act, 21 U.S.C. = 360i, and=20 21 CFR Part 806 - Reports of Corrections and Removals regulation. = Significant=20 deviations include, but are not limited to, the following:

1. Failure to report the correction or removal of a device to FDA, as = required by 21 CFR 806.10(a)(1). For example, your firm identified the = failure=20 of USB Interfaces (USB Upgrade Boxes) to meet any of its specifications; = conducted a field correction by replacing all affected devices for which = you=20 received a complaint including Complaint #105 (Received 03/23/2006), = Complaint=20 #106 (Received 04/10/2006), Complaint #107 (Received 04/10/2006), = Complaint #197=20 (Received- 06/07/2006), and Complaint #206 (Received 06/14/2007); and = failed to=20 report the correction or removal action to FDA.

We have reviewed your response dated August 31, 2007. In your = response you=20 state a "letter to file" will be generated to document the field = corrections. In=20 addition, you state that the recall, corrections, and removals = procedures will=20 be revised. Since you have not reported this, correction and removal to = FDA;=20 have not provided documentation of the correction and removal; and have = not=20 provided the revised recall, corrections, and removal procedures, the = adequacy=20 of the response cannot be determined at this time.

Our inspection and review of your firm's promotional materials and = website=20 also revealed that the MedX Core line of equipment (aka, The Core Spinal = Fitness=20 SystemTM) is a medical device under section 201(h) of the Act because it = is=20 intended for use in the diagnosis of disease or other conditions, or in = the=20 cure, mitigation, treatment, or prevention of disease, or is intended to = affect=20 the structure or function of the body, 21 U.S.C. 321(h). In particular,=20 promotional materials and your firm's website claim that The Core Spinal = Fitness=20 SystemTM "may prevent injuries, remedy chronic back pain and contribute = to disc=20 hydration," "significantly reduce spinal surgeries," and will stretch = and=20 strengthen "the cervical spinal muscles for decompression of the upper = spine."=20 The Act requires that manufacturers of devices that are not exempt = obtain=20 marketing approval or clearance for their products from the FDA before = they may=20 offer them for sale. This helps protect the public health by ensuring = that new=20 devices are shown to be both safe and effective or substantially = equivalent to=20 other devices already legally marketed in this country for which = approval is not=20 required.

The Core Spinal Fitness SystemTM is adulterated under section = 501(f)(1)(B) of=20 the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved = application=20 for premarket approval (PMA) in effect pursuant to section 515(a) of the = Act, 21=20 U.S.C. 360e(a), or an approved application for an investigational device = exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The = device=20 is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), = because you=20 did not notify the agency of your intent to introduce the device into = commercial=20 distribution, as required by section 510(k) of the Act, 21 U.S.C. = 360(k). For a=20 device requiring premarket approval, the notification required by = section 510(k)=20 of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending = before=20 the agency (21 CFR 807.81[b]). The kind of information you need to = submit in=20 order to obtain approval or clearance for your device is described on = the=20 Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will = evaluate=20 the information you submit and decides whether your products may be = legally=20 marketed.

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in = regulatory=20 action being initiated by the Food and Drug Administration without = further=20 notice. These actions include, but are not limited to, seizure; = injunction,=20 and/or civil money penalties. Also, federal agencies are advised of the = issuance=20 of all Warning Letters about devices so that they may take this = information into=20 account when considering the award of contracts. Additionally, premarket = approval applications for Class III devices to which the Quality System=20 regulation deviations are reasonably related will not be approved until = the=20 violations have been corrected. Requests for Certificates to Foreign = Governments=20 will not be granted until the violations related to the subject devices = have=20 been corrected.

We are requesting that you submit to this office, on the schedule = below,=20 certification by an outside expert consultant that he/she has conducted = an audit=20 of your establishment's manufacturing and quality assurance systems = relative to=20 the requirements of the device QS regulation (21 CFR, Part 820). You = should also=20 submit a copy of the consultant's report, and certification by your=20 establishment's Chief Executive Officer (if other than yourself) that he = or she=20 has reviewed the consultant's report and that your establishment has = initiated=20 or completed all corrections called for in the report. The initial=20 certifications of audit and corrections and subsequent certifications of = updated=20 audits and corrections should be submitted to this office by the = following=20 dates:

=95 Initial certifications by consultant and establishment - August = 1, 2008.=20

=95 Subsequent certifications - at least once annually for two (2) = years=20 following your firm's next inspection.

Please notify this office in writing within fifteen (15) working days = from=20 the date you receive this letter of the specific steps you have taken to = correct=20 the noted violations, including an explanation of how you plan to = prevent these=20 violations, or similar violations, from occurring again. Include = documentation=20 of the corrective action you have taken. If your planned corrections = will occur=20 over time, please include a timetable for implementation of those = corrections.=20 If corrective action cannot be completed within 15 working days, state = the=20 reason for the delay and the time within which the corrections will be=20 completed. We will verify all of your corrective actions during our next = inspection of your facility.

Your response should be sent to Matthew Thomaston, Compliance = Officer,=20 Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL = 32751. If=20 you have any questions about the content of this letter please contact = Mr.=20 Thomaston via telephone at (407) 475-4728 or via facsimile at (407) = 475-4769.=20

Finally, you should know that this letter is not intended to be an=20 all-inclusive list of the violations at your facility. It is your = responsibility=20 to ensure compliance with applicable laws and regulations administered = by FDA.=20 The specific violations noted in this letter and in the Inspectional=20 Observations, Form FDA 483 (FDA 483), issued at the closeout of the = inspection=20 may be symptomatic of serious problems in your firm's manufacturing and = quality=20 assurance systems. You should investigate and determine the causes of = the=20 violations, and take prompt actions to correct the violations and to = bring your=20 products into compliance.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District

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FDA/Freedom=20 of Information

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