E Med Future, = Inc., Warning Letter

From: Subject: E Med Future, Inc., Warning Letter Date: Mon, 3 Mar 2008 15:27:04 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_007F_01C87D43.08F42D00" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_007F_01C87D43.08F42D00 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6597c.htm E Med Future, = Inc., Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	Cincinnati District Office Central Region 6751 Steger = Drive=20 Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 = FAX: (513)=20 679-2771

November 29, 2007

WARNING LETTER

CIN-08-33808-05

VIA FEDERAL EXPRESS

Mr. Donald L. Sullivan
CFO/Acting CEO
E Med = Future,=20 Inc.
34 South Clay Street, Suite D
Millersburg, Ohio 44654

Dear Mr. Sullivan:

During an inspection of your firm located in Millersburg, Ohio, on = July 9=20 through 25, 2007, an investigator from the United States Food and Drug=20 Administration (FDA) determined that your firm is the manufacturer=20 (specification developer) for needle disintegration devices (NeedleZap). = Under=20 section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 = U.S.C. =A7=20 321(h), these products are devices because they are intended for use in = the=20 diagnosis of disease or other conditions, or in the cure, mitigation, = treatment,=20 or prevention of disease, or are intended to affect the structure or = function of=20 the body.

This inspection revealed that these devices are adulterated within = the=20 meaning of section 501(h) of the Act, 21 U.S.C. =A7 351(h), in that the = methods=20 used in, or the facilities or controls used for, their manufacture, = packing,=20 storage, or installation are not in conformity with the Current Good=20 Manufacturing Practice (CGMP) requirements of the Quality System (QS) = regulation=20 found at Title 21, Code of Federal Regulations (CFR), Part 820. We = received a=20 response from you dated August 7, 2007, concerning our investigator's=20 observations noted on the Form FDA 483, List of Inspectional = Observations (FDA=20 483), that was issued to you. We address your response below, in = relation to=20 each of the noted violations. These violations include, but are not = limited to=20 the following:

1. Failure to establish and maintain a quality system that is = appropriate=20 for the specific medical devices designed or manufactured and that = meets the=20 requirements of 21 CFR part 820, as required by 21 CFR 820.5.

For example, for the last two years, your firm has not implemented = any of=20 your quality procedures, effectively operating without any quality = system.=20

Your response to this observation appears adequate. We will verify = this=20 corrective action during a future inspection of your firm.

2. Failure to establish management controls as required by 21 CFR = =A7820.20.=20 For example: For the last two years, your firm has not implemented = your=20 complaint procedure, corrective and preventive action procedure,=20 nonconformance procedures, and any other quality procedures, in = violation of=20 the requirement of 21 CFR =A7 820.20(e) that each manufacturer = establish quality=20 system procedures and instructions.

Since June of 2006, your firm has not appointed a management = representative=20 to ensure that quality system requirements are effectively established = and=20 maintained in accordance with the requirements of part 820, and to = report on=20 the performance of the quality system to management with executive=20 responsibility for review, as required by 21 CFR =A7 820.20(b)(3). =

No management reviews have been conducted since May of 2005 = although your=20 management review procedures state that such reviews will be = conducted, at a=20 minimum, every 12 months. [21 CFR =A7820.20(c)]

Your response to this observation appears adequate. Please update = us on the=20 progress of your corrective action regarding this observation. We will = verify=20 your corrective action at a future inspection of your firm.

3. Failure to implement corrective and preventive action = procedures,=20 including procedures for analyzing complaints, returned product, and = other=20 sources of quality data to identify existing and potential causes of=20 nonforming product or other quality problems, and failure to document = all=20 corrective and preventive action activities and results, as required = by 21 CFR=20 =A7 820.100. For example, your firm has been reworking approximately = 15% of the=20 NeedleZap devices received from your contract manufacturer, because of = "an=20 issue with posts that were cracking in the NeedleZap case". = Additionally, you=20 have had many units returned from customers due to broken posts, no = charge,=20 "needlewaste" in electrodes, and bad battery. Your firm has not = determined the=20 root cause of these nonconformances, no corrective actions have been=20 documented, and no trending and analysis of this data has been = performed.

We have reviewed your response to this observation and have = concluded that=20 it is inadequate, because neither the Response Letter, nor your newly = drafted=20 CAPA procedure (attached to the Response Letter), address how the = quality data=20 will be analyzed, including what statistical techniques will be used = to=20 analyze the quality data. Under 21 CFR 820.100(a)(1), you must use = appropriate=20 statistical methodology where necessary to detect recurring quality = problems.=20 See also 21 CFR 820.250 (requiring procedures for identifying valid=20 statistical techniques.)

4. Failure to implement procedures for receiving, reviewing, and = evaluating=20 complaints by a formally designated unit; failure to review, evaluate, = and=20 where required, investigate, complaints; and failure to maintain = appropriate=20 records of investigation, as required by 21 CFR 820.198.

For = example,=20 you have had over 50 devices returned to your firm through your return = material authorization (RMA) system since 2006. More than 30 of these = devices=20 were returned due to broken posts, no charge, "needlewaste" in = electrodes, and=20 bad battery. None of these returns have been evaluated to determine if = they=20 meet the definition of a complaint and no failure investigations of = these=20 devices have been conducted.

We have reviewed your response to this observation and have = concluded that=20 it is inadequate. Neither the new Product Complaint form, nor the = Complaint=20 Handling and Medical Device Reporting procedure (attached to the = Response=20 Letter), addresses documenting your reply (if any) to the complainant, = as=20 required by 21 CFR 820.198(e). Also, please send an update on the = progress of=20 your evaluation of determining if the RMAs received in the last 18 = months are=20 complaints.

Failure to implement your written procedure to control product that = does=20 not conform to specified requirements, including failure to properly = identify,=20 segregate and disposition nonconforming product, as required by 21 CFR = =A7=20 820.90.

For example, the FDA investigator observed nonconforming NeedleZap = devices=20 throughout your firm that were not clearly identified or = dispositioned.=20 Additionally, he found nonconforming devices on a shelf that were = ready for=20 shipment.

6. Failure to establish and maintain rework procedures, including = failure=20 to document rework and retesting that is performed on finished = devices, as=20 required by 21 CFR =A7820.90(b)(2).

For example, your firm is examining all NeedleZap devices received = from=20 your contract manufacturer and has reworked about 15% of these devices = due to=20 issues with the post cracking in the case and wrong screws being used. = This=20 rework and any retesting are not documented. You also do not have a = written=20 procedure on how to perform the rework and the retesting that must be=20 performed.

We have reviewed your response to this observation and have = concluded that=20 it is inadequate, because it does not include a written rework = procedure and=20 does not address how rework will be documented.

7. Failure to implement procedures for calibration, including = failure to=20 perform calibration on testing equipment, as required by 21 CFR=20 =A7820.72(b).

For example, the multimeter used to test the NeedleZap after rework = is=20 performed has not been calibrated. Additionally, your written = calibration=20 procedure, which requires all equipment to bear a calibration label = and be=20 calibrated at a maximum of 12-months interval, is not being followed. =

Your written response is inadequate, because it does not = specifically=20 address the calibration of the multimeter. It only states that all = procedures=20 will be completely revised.

8. Failure to ensure that all personnel are trained to adequately = perform=20 their assigned responsibilities; and failure to implement your = training=20 procedure, as required by 21 CFR =A7820.25(b).

For example, = there is no=20 documentation of any training of any current employees with regard to = their=20 assigned responsibilities, although your training procedures require=20 documentation of training. In addition, an employee assigned to = receive=20 customer calls on problems with the NeedleZap indicated that she in = fact has=20 received no training on how to perform her assigned tasks, including=20 documenting customer complaints.

Your written response is inadequate, because it does not = specifically=20 address training. It only states that all procedures will be = completely=20 revised.

9. Failure to conduct quality audits; and failure to implement = audit=20 procedures to assure that the quality system is in compliance with the = established quality systems requirements and to determine the = effectiveness of=20 the Quality Systems, as required by 21 CFR =A7 820.22.

For example, you have not performed quality audits for two years. =

Your response states that an audit of your firm would be completed = by=20 September 30, 2007. Please inform us if the audit has been completed, = and if=20 not, when it will be completed.

The inspection also revealed that your NeedleZap is misbranded under = section=20 502(t)(2) of the Act, 21 U.S.C. =A7 352(t)(2), in that your firm failed = or refused=20 to furnish material or information respecting the device that is = required by or=20 under section 519 of the Act, 21 U.S.C. =A7 360i, and 21 CFR Part 803 = Medical=20 Device Reporting (MDR) regulation. Significant deviAtions include, but = are not=20 limited to, the following:

1. Failure to submit an MDR to FDA within 30 days of receiving = information=20 that reasonably suggest that your marketed device has malfunctioned = and would=20 be likely to cause or contribute to a death or serious injury if the=20 malfunction were to recur, as required by 21 CFR = =A7803.50(a)(2).

For=20 example, in February of 2005, your firm received a copy of a Voluntary = MedWatch report from a doctor, which described the nurse being stuck = by a=20 needle that had "worked its way out of a side seam" of a NeedleZap = device. It=20 further states that many of the patients treated with these needles = have HCV=20 and HIV; and that the nurse was evaluated and treated for high risk = exposure.=20 You did not report this to FDA within 30 days as a malfunction MDR. =

Your response to this observation appears adequate, and subsequent = to the=20 date of the inspection, your firm submitted MDRs on this event to FDA. = Your=20 response also states that you are reviewing all NeedleZap return = material=20 authorizations (RMAs) for the last 18 months, and are evaluating these = RMAs to=20 determine if they are reportable under 21 CFR Part 803, Medical Device = Reporting. Please update us on the progress and findings of this = review.

2. Failure to conduct an investigation of each MDR event and = evaluate the=20 cause(s) of the event, as required by 21 CFR = =A7803.50(b)(3).

For=20 example, there is no evidence to show that you conducted a failure=20 investigation on the complaint (T0002) involving the nurse who picked = up a=20 NeedleZap unit and was stuck by a needle protruding from the side of = the=20 device. This type of event is considered a malfunction. Also, a = telephone=20 conversation documented in the complaint file states, "Action taken to = the new=20 units would not have the same problem." It is unclear what, if any, = actions=20 were taken. According to your MDR reporting procedures, it states that = "serious event/incidents and near incidents shall be investigated and = reported=20 as appropriate." Each manufacturer is responsible for conducting an=20 investigation of each event and evaluating the cause of the event. If = it is=20 determined that an event is not reportable, the decision must be = documented as=20 described in 21 CFR =A7 803.18.

This observation was mad after the FDA 483 was issued. Your = response did=20 not address why a failure investigation for this complaint was not = conducted.=20

Although E-Med Future, Inc. has MDR reporting procedures, it was = noted that=20 some aspects of the procedure are incomplete or obsolete. For example: =

MDR report and respective time frame are not addressed, i.e., = Supplement=20 MDR reports, 21 CFR =A7 803.56.

The procedures do not contain a specific definition and procedure = for=20 addressing MDR reportable malfunctions. You could address this by = defining=20 "near incident" as including an MDR reportable malfunction or by = adding a=20 separate definition/procedure for MDR malfunctions.

Item #6.8.2 of your procedures addresses the submission of Annual = Reports=20 to FDA. As a result of statutory changes enacted in 1997, MDR = regulations no=20 longer require submission of annual certifications of the number of = MDRs=20 filed. We recommend that you thoroughly review your MDR procedures to = ensure=20 that they will promote compliance with the requirements of 21 CFR part = 803.=20

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

Please notify this office within fifteen (15) working days from the = date you=20 receive this letter of the specific steps you have taken to correct the = noted=20 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 actions you have taken. If your planned corrective = actions=20 will occur over time, please include a timetable for implementation of = those=20 corrections. If corrective action cannot be completed within 15 working = days,=20 state the reason for the delay and the timeframe within which the = correction=20 will be completed.

Your response should be sent to Ms. Gina Brackett, Compliance = Officer, Food=20 and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If = you have=20 any questions concerning the contents of this letter, you may contact = Ms.=20 Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to = her at=20 (513) 679-2773.

Finally, you should know that this letter is not intended to be an=20 all-inclusive list of violations at your facility. It is your = responsibility to=20 ensure compliance with applicable laws and regulations administered by = the 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 action to correct the violations and to = bring your=20 products into compliance.

Sincerely,

/S/

Carol A. Heppe
District Director
Cincinnati District =

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