TOSOH AIA, = Inc. Warning Letter

From: Subject: TOSOH AIA, Inc. Warning Letter Date: Mon, 3 Mar 2008 10:16:11 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0037_01C87D17.9AAA9710" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0037_01C87D17.9AAA9710 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6366c.htm TOSOH AIA, = Inc. Warning Letter

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	2098 Gaither Road Rockville, MD = 20850

MAY 9 2007

WARNING LETTER

VIA FEDERAL EXPRESS {AND FACSIMILE}

Yoshihiko Nagata, Ph.D.
Plant Manager, Diagnostic Reagents = Production=20
TOSOH AIA, Inc.
2, Iwasekoshi-Machi
Toyama City. Japan

Dear Dr. Nagata:

During an inspection of your firm located in Toyama City, Japan on = December=20 4, 2006 through December 7, 2006, investigator(s) from the United States = Food=20 and Drug Administration (FDA) determined that your firm manufactures = AIA-PACK PA=20 PSA Assay and ST AIA-PACK PA PSA. Under section 201(h) of the Federal = Food.=20 Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products arc = devices=20 because they are intended for use in the diagnosis of disease or other=20 conditions or in the cure, mitigation, treatment, or prevention of = disease. or=20 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, current procedure concerning electronic data storage in the or = the=20 facilities or controls used for, their manufacture, packing, storage, or = installation are not in conformity with the Current Good Manufacturing = Practice=20 (CGMP) requirements of the Quality System (QS) regulation found at Title = 21,=20 Code of Federal Regulations (C.F.R.), Part 820. We = received a=20 response from Charles P. Gill, RA/Quality Assurance Manager dated = December 22,=20 2006 concerning our investigator's observations noted on the Form FDA = 483, List=20 of Inspectional Observations that was issued to you. We address this = response=20 below, in relation to each of the noted violations. These violations = include,=20 but are not limited to, the following:

1. Failure to perform design verification to confirm that the = design output=20 meets the design input requirements, as required by 21 CFR=20 820.30(f).

For example: the protocol entitled "Verification Method Protocol" = requires=20 that the samples [redacted] containing the monoclonal=20 antibodies, derived from the bioreactors, be stored at=20 [redacted]C and [redacted]C for=20 [redacted] and [redacted] days: = however, the=20 final report entitled "Design Process Change Verification" document = revealed=20 that the samples were placed in an incubator at = [redacted]C at=20 [redacted] relative humidity suggesting that the = humidity was=20 neither monitored nor recorded; you failed to document the storage = details such=20 as the initial placement, any movement and/or the identification of the=20 refrigerators in which the samples were stored at = [redacted]C=20 and tested at months [redacted] and = [redacted]=20 as required by their established stability protocol = [redacted]=20 you failed to adhere to the requirements established by the stability = protocol=20 [redacted] in that, the method for tracking (i.e. = Microsoft=20 Excel) the number of samples placed in the incubator was = unauthenticated.

We have reviewed your response and have concluded that it is = inadequate=20 because although, sections "7.3 Design and Development", "7.5.1.2 = Storage of=20 Record" and "List of Quality Record" of the "Quality System Procedure" = were=20 revised to ensure that relevant data is explicitly included and = controlled in=20 the procedure, you failed to verify that the design outputs met the = desired=20 inputs. Secondly. the format of the equipment control ledger for = refrigerators=20 and incubators: as well as, the new record format used in the validation = study=20 have been revised and implemented to fully document design validation=20 activities: however, no documentation was provided to demonstrate that=20 measurable design outputs were adequately defined to complete design = validation=20 activities.

2. Failure to store records so as to minimize deterioration, = prevent loss=20 and back up of automated data processing systems as required by 21 CFR = 820.180.

For example: the electronic data did not correlate with the paper = records;=20 you had not established an electronic data back-up procedure; and = finally, data=20 was copied onto the server from one system to the next via floppy: = therefore, no=20 limited access or data protection had been established.

We have reviewed your response and have concluded that it is = inadequate=20 because you failed to encrypt and/ or physically secure your data = back-up system=20 to comply with the requirements to prevent deterioration or deletion of = the=20 analyzer data. Your revision to the current "Quality System Procedure", = with=20 regard to the electronic data storage, to include: a data back-up system = using=20 CD-R (non-rewritable CD); as well as, to require the most responsible = person to=20 make photocopies of the serial paper print out and maintain an = electronic file=20 has been noted.

3. Failure to adequately validate the intended use of this PC and = its=20 software, as required by 21 CFR 820.70(i).

For example: the dedicated PC [redacted] attached to = the [redacted] was not secure in that access to the = data on=20 [redacted] was not granted by a unique username and = password or=20 equivalent method; there as no documentation associated with the = electronic data=20 for whom was responsible for collection of the analytical results as = several=20 quality control personnel have access to the [redacted] = no=20 software changes in the study data could be detected as there was no = audit trail=20 capability; and finally, the electronic data did not correlate with the = paper=20 records.

We have reviewed your response and have concluded that it is = inadequate=20 because no system validation was conducted to ensure accuracy, = reliability,=20 consistent intended performance, and the ability to discern invalid or = altered=20 records.

A follow tip inspection will be required to assure that corrections = are=20 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 violation(s), or similar violation(s). from occurring again. Include=20 documentation of the corrective action you have taken. If your planned=20 corrections will occur over time, please include a timetable for = implementation=20 of those corrections. If corrective action cannot be completed within 15 = working=20 days. state the reason for the delay and the time within which the = corrections=20 will be completed. If the documentation is not in English, please = provide a=20 translation to facilitate our review.

Your response should be sent to: James Woods (HFZ-440), 2098 Gaither = Road,=20 Rockville, MD 20850. If you have any questions about the content of this = letter=20 please contact: Cecily Jones at 240-276-0493 or 240-276-0652.

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

Sincerely yours,

/S/

Steven I. Gutman. M.D., M.B.A.
Director
Office of In Vitro = Diagnostic=20
Device Evaluation and Safety
Center for Devices and Radiological = Health=20

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FDA/Freedom=20 of Information

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