G&B Electronic Designs Limited, Warning = Letter

From: Subject: G&B Electronic Designs Limited, Warning Letter Date: Mon, 3 Mar 2008 08:42:45 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0036_01C87D0A.8D99C8F0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0036_01C87D0A.8D99C8F0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6338c.htm G&B Electronic Designs Limited, Warning = Letter

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Department of Health and Human Services	Public Health = Service=20 Food and Drug Administration
	9200 Corporate Boulevard Rockville, Maryland=20 20850

APR 24 2007

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Gary McBrown
Quality Manager
G&B Electronic Designs = Limited=20
54, Woolmer Industrial Estate
Bordon, Hampshire, GU35 9QF =
United=20 Kingdom

Dear Mr. McBrown:

During an inspection of your firm located in Bordon, Hampshire, from = November=20 20-23, 2006, an investigator from the United States Food and Drug = Administration=20 (FDA) determined that your firm manufactures the Tracklt and NicoletOne=20 Ambulatory Electroencephalograph Recorder devices. Under section 201(h) = of the=20 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these = products=20 are devices because they are intended for use in the diagnosis of = disease or=20 other conditions or in the cure, mitigation, treatment, or prevention of = disease, or are intended to affect the structure or function of 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 (C.F.R.), Part 820. These = violations include, but are not limited to, the following:

1. Failure to assure that when the results of a process cannot be = fully=20 verified by subsequent inspection and test, the process shall be = validated with=20 a high degree of assurance and approved according to established = procedures, as=20 required by 21 CFR 830.75(a). For example:

a. Automated machines were used for the screening, placing, and = soldering=20 processes for the circuit boards used in the NicoletOne device but no=20 procedures were established to validate the processes to assure that = specified=20 requirements are met.

b. There are no written procedures for ensuring the installation,=20 operation, or performance of the NicoletOne device for the automated = screen=20 printing machine, automated pick and place machine, and the reflow = oven.=20

We have reviewed your response and have concluded that it is = inadequate=20 because you have confused process validation with equipment = qualification. Also,=20 no procedures have been submitted for review and no timetable for = corrective=20 action and response was indicated.

2. Failure to assure that when computers or automated data processing = systems=20 are used as part of the production or quality system the manufacturer = shall=20 validate computer software for its intended use according to an = established=20 protocol, as required by 21 CFR 820.70(i). For example, electronic = records are=20 used, but there was no software validation. No procedures are = established to=20 validate for its intended purpose the Microsoft Word or Microsoft Excel = software=20 used in creating and maintaining nonconformance records, product return = records,=20 internal audit corrective action records, or preventive action records. =

We have reviewed your response and have concluded that it is = inadequate=20 because off-the-shelf software must be validated for its intended = purpose. You=20 have stated that a review will be conducted of the existing forms and an = implementation of a new record control system to meet FDA requirements = will be=20 pursued. A new system may not be necessary; however, no procedures have = been=20 submitted for review and no timetable for corrective action and response = was=20 indicated.

3. Failure to establish and maintain adequate procedures to control = product=20 that does not conform to specified requirements . The evaluation of=20 nonconforming product shall include a determination of the need for an=20 investigation and notification of the persons responsible for the=20 nonconformance. The evaluation of nonconforming product and any = associated=20 investigation shall be documented, as required by 21 CFR 90(a). For = example,=20 nonconformance report no. 1073 describes the need to relabel a device by = a=20 customer. The record does not include any analysis or other = documentation of an=20 evaluation into this nonconformance.

We have reviewed your response and have concluded that it is = inadequate=20 because it does not address the FDA 483 citation and it appears that you = are=20 unaware there is no requirement to report to FDA all nonconformances. = FDA must=20 be notified only under the requirements of the Medical Device Reporting=20 regulation, the Corrections and Removals regulation, and the Recall = regulation.=20

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

4. Failure to submit a written report to FDA of any=20 correction or removal of a device, as required by 21 CFR 806.10. For = example,=20 nonconformance report no. 1073 describes the need to relabel a device by = a=20 customer. The record does not include a heath hazard analysis or other=20 documentation of an evaluation to justify why a field correction was not = reported to the FDA.

We have reviewed your response and have = concluded=20 that it is inadequate because you did not provide justification for not=20 reporting the correction or removal action to FDA which shall contain=20 conclusions and any follow-ups, and be reviewed and evaluated by a = designated=20 person.

Our inspection also revealed that your Tracklt and NicoletOne = Ambulatory EEG=20 devices are misbranded under section 502(o) of the Act, 21 U.S.C. = 352(o), in=20 that your firm failed or refused to furnish material or information = respecting=20 the device that is required by or under section 510 of the Act, 21 = U.S.C.=20 360(i)(1) and 21 C.F.R. Part 807 - Establishment Registration and Device = Listing=20 for Manufacturers and Initial Importers of Devices regulation. = Significant=20 deviations include, but are not limited to, the following:

5. Failure to assure that any establishment within any foreign = country=20 engaged in the manufacture, preparation, propagation, compounding, or = processing=20 of a device that is imported or offered for import into the United = States shall=20 register and list such devices in conformance of such requirements of = Subparts=20 B. The official correspondent for the foreign establishment shall = facilitate=20 communication between the foreign establishment's management and = representatives=20 of the Food and Drug Administration, as required by 21 CFR 807.40(a). = For=20 example, the inspection revealed your firm has not registered or listed = with the=20 FDA and you are importing devices into the United States.

We have reviewed your response and have concluded that it is = inadequate=20 because you have not registered or listed your devices with the FDA, and = have=20 not identified your US agent.

A followup inspection will be required to assure that corrections are = adequate. We will contact the appropriate people and request an = establishment=20 re-inspection. An FDA trip planner will be in touch with you to arrange = a=20 mutually convenient date for this 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, which may include detaining your devices without physical = examination=20 upon entry into the United States until the corrections are completed, = Section=20 801(a) of the Act (21 U.S.C. =A7 381(a)). Also, U.S. federal agencies = are advised=20 of the issuance of all Warning Letters about devices so that they may = take this=20 information into account when considering the award of contracts. = Additionally,=20 premarket approval applications for Class III devices to which the = Quality=20 System regulation deviations are reasonably related will not be approved = until=20 the violations have been corrected. Requests for Certificates to Foreign = Governments will not be granted until the violations related to the = subject=20 devices have been corrected.

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.

Your response should be sent to: Nicole L. Wolanski, Chief, = Cardiovascular=20 and Neurological Devices Branch, Division of Enforcement B, Office of=20 Compliance, Center for Devices and Radiological Health, 2098 Gaither = Road,=20 Rockville, Maryland 20850. If you have any questions about the content = of this=20 letter please contact her via telephone at 240-276-0295, or via fax at=20 240-276-0129.

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 yours,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center = for=20 Devices and
Radiological Health

FDA/Freedom of Information=20

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