Fall = Prevention Technologies, Warning Letter

From: Subject: Fall Prevention Technologies, Warning Letter Date: Wed, 10 Sep 2008 13:05:57 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C91345.F716FD80" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C91345.F716FD80 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6906c.htm Fall = Prevention Technologies, 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

August 27, 2008

VIA FEDERAL EXPRESS

WARNING LETTER CIN-08-28666-22

Dr. Frank S. Scarpino, CEO
Fall Prevention Technologies
4601 = Gateway=20 Circle
Kettering, OH 45440-1713

Dear Dr. Scarpino:

During an inspection of your firm located in Kettering, Ohio, from = May 5,=20 2008 through May 21, 2008, an investigator from the United States Food = and Drug=20 Administration (FDA) determined that your firm manufactures the = Balanceback iVNG=20 device intended for recording, viewing, and analyzing eye movements in = support=20 of identifying balance disorders in human patients. Under section 201(h) = of the=20 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. =A7 321(h), = these=20 products are devices because they are for use in the diagnosis of = disease or=20 other conditions or the cure, mitigation, treatment, or prevention of = disease,=20 or are intended to affect the structure or function of the body.

The inspection revealed that these devices are adulterated within the = meaning=20 of section 501(h) of the Act (21 U.S.C. =A7351(h)), in that the methods = used in,=20 or the facilities or controls used for their manufacture, packing, = storage, or=20 installation are not in conformity with the Current Good Manufacturing = Practices=20 (CGMP) requirements of the Quality System (QS) regulation found at Title = 21,=20 Code of Federal Regulations (CFR), Part 820. We received two responses = from=20 Daniel K. Grossman, Quality Manager, dated June 3, 2008 and July 14, = 2008,=20 concerning our investigator's observations noted on the Form FDA 483, = List of=20 Inspectional Observations that was issued to him at the conclusion of = the=20 inspection. We address these responses below, in relation to each of the = noted=20 violations. The violations include, but are not limited to, the = following:

1. Failure of management with executive responsibility to ensure = that an=20 adequate and effective quality system is implemented and maintained at = all=20 levels of the organization, as required by 21 CFR =A7 820.20. For = example:

a) Your firm has not established adequate quality system = procedures, as=20 required by 21 CFR =A7 820.20(e), for corrective and preventive = action (CAPA),=20 complaints, design controls,and records.

b) Your quality audits, as required by 21 CFR =A7 820.22, did not = assure=20 that the firm's quality system is in compliance with the established = quality=20 system requirements. Specifically, your audits failed to identify=20 significant deficiencies in your firm's quality systems, including = but not=20 limited to, CAPA, design controls, complaints, and=20 records.

We have reviewed your response to these observations but are unable = to assess=20 its adequacy because you still need to retrain the Quality Management=20 Representative and other employees, and this training is not scheduled = for=20 completion until September 30, 2008.

2. Failure to adequately establish and maintain procedures for = implementing=20 corrective and preventive action, as required by 21 CFR =A7 820.100. = For=20 example:

a) Your documentation of CAPA activities was not complete, as = required by=20 21 CFR =A7820.100(b). Specifically, neither your CAPA nor data = analysis=20 procedures identify a complete list of quality data sources, the = process for=20 investigation of nonconformities, the verification/validation = required of=20 the proposed correction, or the process of implementing the = corrective=20 action.

b) You have failed to implement the CAPA system, as required by = 21 CFR=20 820.100(a). Specifically, you have made numerous changes to the = software for=20 the iVNG Balanceback system as a result of complaints but did not = initiate a=20 CAPA for any of these changes.

c) You have failed to adequately analyze quality data sources to = identify=20 existing and potential causes of nonconforming product or other = quality=20 problems, as required by 21 CFR =A7 820.100(a)(1). Specifically, you = did not=20 adequately trend all complaints to identify existing and potential = quality=20 problems, and the trending that was conducted was insufficient to = detect=20 such problems. You also failed to review service records to = determine=20 whether they were complaints that needed to be documented in the = complaint=20 system.

We have reviewed your response but are unable to assess its adequacy = because=20 you still need to update
and implement these procedures and to = retrain=20 employees and these corrective actions are not scheduled
for = completion=20 until October and November, 2008 respectively.

3. Failure to adequately implement procedures for receiving, = reviewing, and=20 evaluating complaints, as required by 21 CFR =A7 820.198. For example, = the=20 investigator determined that out of 128 records reviewed, your firm = had=20 classified 50 as "concerns" when they met the definition of a = complaint as=20 defined by 21 CFR =A7 820.3(b), and your procedure QAP 0502, = Distinguish Product=20 Concern vs. Product Complaint. Further, all but one of the 128 records = reviewed lacked documentation of an investigation or an explanation = why an=20 investigation was not conducted.

We cannot evaluate whether your response to this item is adequate = based on=20 the information provided.
Please provide our office with additional=20 information concerning the new tool that you will be using to manage and = organize your complaints.

4. Failure to assure that service reports include applicable test = and/or=20 inspection data following the completion of service, as required by 21 = CFR =A7=20 820.200(d)(6). For example, 19 of the 19 service records reviewed did = not have=20 documentation reflecting that the device was tested or inspected after = the=20 repair to ensure the device met its specifications.

Your response indicates that this item will be corrected by November = 14,=20 2008. Please provide an update on the status of this corrective = action.

5. Failure to review associated data and documentation for all = finished=20 devices before they are released for distribution, as required by 21 = CFR =A7 820=20 .80(d)(2). For example, 5 of 11 of the finished iVNG device history = records=20 reviewed by the investigator revealed that the devices had been = released prior=20 to written approval.

We acknowledge that you have fired one employee over this incident = and hired=20 and trained a new employee. We note that page 1 of the submitted = training record=20 for the new employee (Page 1 of Tab 3 of your response) contains spaces = for=20 training in procedures; however, none of these spaces are completed. In = your=20 response, please provide a copy of your general training procedure and = the=20 procedure for completing this form. Also, please provide an explanation = for why=20 the form is incomplete.

6. Failure to establish a Device Master Record for the iVNG, as = required by=20 21 CFR =A7 820.181.

This item is not scheduled for completion until January 15, 2009. = Please=20 provide an explanation for the delay in completing corrective action for = this=20 item.

7. Failure to adequately implement procedures to control the design = of a=20 device in order to ensure that specified design requirements are met, = as=20 required by 21 CFR =A7 820.30. For example:

a) Your design plan for the iVNG Balanceback system does not = demonstrate=20 that the design was developed in accordance with the approved design = plan=20 and design control requirements, as required by 21 CFR =A7 = 820.30(j).

b) Your validation of your device design is incomplete in that = the firm=20 has not established a protocol for conducting validation testing and = did not=20 validate the software to ensure that devices conform to the defined = user=20 needs and intended uses, as required by 21 CFR =A7820.30(g). = Specifically, you=20 have made 1,900 revisions to the software in three years without = conducting=20 validation testing.

c) You have not established and implemented adequate procedures = for the=20 identification, documentation, validation, review, and approval of = design=20 changes before their implementation, as required by 21 CFR =A7 = 820.30(i). None=20 of the design control procedures include information on how to make = changes=20 to the design. There have been numerous changes to the hardware and = desktop=20 and laptop software since the original design; however, there have = been no=20 engineering change orders or validation or, where appropriate, = verification=20 testing for any of these design changes. =

You do not project complete correction for these items (which = correspond to=20 items 1-4 of the Form FDA 483) until December 2008. Please provide an = update on=20 the status of these corrections.

8 . Failure to store records in a manner to minimize deterioration = and=20 loss, as required by 21 CFR =A7 820.180. For example, you could not = locate=20 service records requested by the FDA investigator.

Moreover, the firm could not access its computer program for = documenting=20 complaints prior to August 2007 and no other copies of these = complaints are=20 available.

We acknowledge your intention to update procedures and organize your=20 documents in order to prevent their loss. In your response, please = provide an=20 update on your progress. Also, please provide an update on your efforts = to=20 locate the requested records that you were not able to locate during the = inspection.

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 FDA without further notice. These actions = include, but=20 are not limited to, seizure, injunction, and/or civil money penalties. = Also,=20 federal agencies are advised of the issuance of all Warning Letters = about=20 devices so that they may take this information into account when = considering the=20 award of contracts. Additionally, no premarket approval applications for = Class=20 III devices to which the QS regulation deviations are reasonably related = will 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.

We acknowledge your two letters in response to the Form FDA 483 that = was=20 issued at the conclusion of the inspection. We note that you promise = gradual=20 implementation of corrective actions over the next five months. Please = notify=20 this office in writing within fifteen (15) working days from the date = you=20 receive this letter as to the progress you have made in correcting these = violations. Please address the specific issues raised above, and provide = an=20 explanation for why your corrective action for these deficiencies cannot = be=20 accomplished in a more timely fashion.

Your response should be sent to: Stephen J. Rabe, Compliance Officer. = If you=20 have any questions about the content of this letter please contact: Mr. = Rabe at=20 513-679-2700 ext 163 or FAX 513-679-2775

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, issued at the closeout of the inspection may = be=20 symptomatic of serious problems in your firm's manufacturing and quality = 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/

Toniette K. Williams
Acting District Director

cc: David K. Grossman
Quality Manager
Fall Prevention = Technologies=20

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