Trionix = Research Laboratory, Inc., Warning Letter

From: Subject: Trionix Research Laboratory, Inc., Warning Letter Date: Tue, 10 Jun 2008 14:59:07 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C8CB0A.884601E0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C8CB0A.884601E0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/archive/g6139d.htm Trionix = Research Laboratory, Inc., Warning Letter

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

November 21, 2006

WARNING LETTER
CIN-06-31049-05

VIA FEDERAL EXPRESS

Chun B. Lim
President and CEO
Trionix Research Laboratory, = Inc.
8037=20 Bavaria Road
Twinsburg, OH 44087

Dear Mr. Lim:

During an inspection of your firm located in Twinsburg, OH on July 25 = through=20 August 9, 2006, an investigator from the United States Food and Drug=20 Administration (FDA) determined that your firm manufactures nuclear = imaging=20 devices. 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.

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 manufacturing, packing, = storage,=20 or installation are not in conformity with the Current Good = Manufacturing=20 Practice (CGMP) requirements of the Quality System (QS) regulation found = at=20 Title 21, Code of Federal Regulations (C.F.R.), Part 820. These=20 violations include, but are not limited to, the following:

1) Failure to establish procedures for, and to implement, a = corrective and=20 preventive action to prevent the recurrence of nonconforming product. = [21 CFR=20 820.100(a)]

Specifically, your firm received a complaint on April 22, 2002 that = the=20 detector head on the Biad nuclear imaging system fell and trapped a = patient.=20 You determined that this failure was caused by the shaft of the ball = screw=20 breaking. You also determined that the shaft broke because of system = age and=20 metal fatigue. Your firm developed a retrofit which included a new = "acme"=20 screw to prevent the detector head from dropping if a similar = situation=20 occurs. The retrofit also included a gear and belt change, which makes = the=20 motion speed of the device slower. A memo, dated May 22, 2002, to "All = Field=20 Service Engineers" stated that your firm would notify all customers of = this=20 retrofit and that retrofits would begin in July of 2002. The retrofit = to these=20 devices has not been performed and there is no justification as to why = this=20 corrective action has not been implemented.

You informed the investigator during the inspection that you will = conduct a=20 recall of all Biad Systems which are still in use. You stated that = this=20 retrofit will not occur until January of 2007, so your firm can = develop test=20 procedures, assure this corrective action has been validated, and = train all=20 the Field Service Engineers. Please update us on the status of this = corrective=20 action.

2) Failure to implement procedures for receiving, reviewing, and = evaluating=20 complaints; to maintain complaint files; and to review and evaluate = complaints=20 to determine if an investigation is necessary. [21 CFR 820.198(a),(b), = and=20 (c)]

Specifically, your complaint procedure (T002013-Rev B) has not been = used=20 since your former Quality Assurance Manager left your company over = five years=20 ago, and no person has been designated to handle complaints. = Additionally,=20 oral complaints are recorded on paper, and this paper is discarded = after=20 service is dispatched. Furthermore, service reports are not reviewed = to=20 determine if the service constitutes a complaint.

3) Failure to assure that the nuclear imaging device met all final=20 acceptance and in-process acceptance criteria and to authorize the = release of=20 the device by the signature of a designated individual prior to = distribution.=20 [21 CFR 820.80(c)(d)]

Specifically:

The Device History Record for the Triad XLT nuclear imaging = system,=20 serial #231, revealed that over 30 checks/tests, that are required = to be=20 performed, were not documented as being completed.

The Device History Record for the Triad XLT nuclear imaging = system,=20 serial #231, also revealed that during in-process testing, several = voltage=20 readings, and the hard limit switch's readings were not within=20 specifications. There is no documented acceptance of these=20 deviations.

4) Failure to ensure that equipment is routinely calibrated and = inspected.=20 [21 CFR 820.72(a)]

Specifically, the FDA investigator found that all testing/measuring = equipment used to manufacture and test components and finished devices = that=20 the investigator reviewed had expired calibration. A total of three=20 oscilloscopes, two multimeters, a Ground and Dielectric tester, and 65 = different hand crimping tools had expired calibration.

5) Failure to control products that do not conform to = specifications.=20 [820.90(a)]

Specifically, the FDA investigator found materials that have been=20 obsoleted, scrapped or found to be nonconforming scattered throughout = your=20 facility without being properly identified or segregated. = Additionally,=20 returned units that may be refurbished are not clearly=20 identified.
Furthermore, the disposition of these products is not=20 documented.

6) Failure to use the design process for the design changes made to = the=20 Biad nuclear imaging system and failure to have written design change = control=20 procedures. [21 CFR 820.30(i)]

Specifically, the design change (retrofit) your firm made to the = Biad=20 nuclear imaging system as a result of a complaint that the detector = head on=20 the Biad nuclear imaging system fell and trapped a patient (See item = #1 above)=20 was not performed using design controls. There is no formal approval = of the=20 change, no risk assessment was documented, and there is no = verification/=20 validation protocol.

7) Failure of management with executive responsibility to assure = that an=20 adequate and effective quality system has been fully implemented and=20 maintained at all levels of the organization. [21 CFR 820.20]

Specifically, your firm is not conducting internal quality audits,=20 performing management reviews, capturing/managing complaints, = generating=20 corrective/preventive actions, and has not had a person manage the = quality=20 system since 1998.

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

Failure to submit a written report to FDA regarding the correction = that=20 your firm made to the detector head of the Biad Nuclear Imaging = devices, as=20 required by 21 C.F.R. Part 806.10. This correction was initiated to = remedy a=20 violation of the Act caused by the device which may present a risk to = health=20 posed by the device. On May 13 and 14, 2002, your firm retrofitted the = detector head of the Biad Nuclear Imaging System with acme screws and = changed=20 the gear and belt to prevent the detector head from = dropping.

FDA regulations require manufacturers and importers to submit a = written=20 report to FDA of any correction or removal of a device if the correction = or=20 removal was initiated to reduce a risk to health posed by the device. = See 21 CFR=20 806.10 (a)(1). This report must be submitted to FDA within 10 working = days of=20 initiating the correction or removal. See 21 C.F.R 806.10(b). Because = your=20 actions described above meet the definition of a "correction" in 21 CFR = 806.2(d)=20 and because they were initiated to reduce a risk to health, your failure = to=20 report them until the issue was raised by our investigator violated 21 = CFR=20 806.10(a)(1).

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 riot 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 = applications for Class III devices to which the Quality System = regulation=20 deficiencies are reasonably related will not be approved until the = violations=20 have been corrected. Requests for Certificates to Foreign Governments = will not=20 be granted until the violations related to the 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 = these noted=20 violations, including an explanation of how you plan to prevent these=20 violations, or similar violations, from occurring again. Include = documentation=20 for the corrective actions you have taken. If your planned corrections = will=20 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 time within which the corrections = will be=20 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 = FDA. The=20 specific violations noted in this letter and in the Inspectional = Observations,=20 Form FDA 483, issued at the closeout of the inspection may be = symptomatic of=20 serious problems in your firm's manufacturing and quality assurance = systems. You=20 should investigate and determine the causes of the violations, and take = prompt=20 actions to correct the violations to bring your products into = compliance.

Sincerely,

/s/

Carol A. Heppe
District Director
Cincinnati District

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