Tomita = Pharmaceutical Co., Ltd Warning Letter

From: Subject: Tomita Pharmaceutical Co., Ltd Warning Letter Date: Mon, 3 Mar 2008 11:07:24 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0081_01C87D1E.C24546B0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0081_01C87D1E.C24546B0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6630c.htm Tomita = Pharmaceutical Co., Ltd Warning Letter

FDA Home = Page | Search FDA Site | FDA A-Z Index | Contact FDA

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Department of Health and Human Services	Public Health Service Food and Drug = Administration
	Rockville, MD 20857

Warning Letter

Via FedEx

WL: 320-07-04

JAN 14 2008

Mr. Yoshihiro Tomita
Chief Executive Officer and Chairman =
Tomita=20 Pharmaceutical Co., Ltd
85-1 Aza-maruyama, Akinokami, Seto-cho=20
Naruto-City, Tokushima 7771-0360
Japan

Dear Mr. Tomita:

We have completed our review of the inspection of your pharmaceutical = manufacturing facility in Tokushima, Japan, by Investigator Katherine E. = Jacobitz and Analyst Luis M. Burgos Medero, during the period of July = 31-August=20 2, 2007. The inspection revealed significant deviations from U.S. = Current Good=20 Manufacturing Practice (CGMP) in the manufacture of active = pharmaceutical=20 ingredients (APIs).

The deviations were presented on an Inspectional Observations = (FDA-483) form=20 at the close of the inspection to Mr. [redacted] Quality Assurance = Division=20 Manager and Product Security Pharmacist. These CGMP deviations cause = your APIs=20 to be adulterated within the meaning of section 501(a)(2)(B) of the = Federal=20 Food, Drug, and Cosmetic Act (FD&C Act). In addition, your firm = failed to=20 provide copies of documents requested throughout the inspection.

During the close-out meeting, Mr. [redacted] = indicated that=20 the firm would respond in writing to the FDA-483 observations within 30 = days. We=20 have not yet received a written response. Based on the review of the = EIR,=20 specific areas of concern include, but are not limited to:

Laboratory system

1. The analyst worksheets were deficient in that the following was = observed:=20

a) There was no reference to the analytical test methods used
b) = There=20 was no reference to the [redacted] or instruments used =
c)=20 There was no reference to the manufacturer's standards and/or the lot = number=20 used
d) There were unidentified post-it notes with the sample and = standard=20 weights and no reconcilability of the batches being tested
e) There = were=20 weights reported without indicating the gross, tare, or net weight

This is a repeated deviation from the August 1-3, 2005, inspection of = your=20 site. After that inspection, in your response dated 8/29/05, your firm = stated=20 that "We begin to apply the record details of analyst work, calculations = and=20 pertinent information in any of analyses such as = [redacted] and=20 so on by the end of this year."

Please note that laboratory control records should include complete = data=20 derived from all tests conducted to ensure compliance with established=20 specifications and standards. This includes the signature of the person = who=20 performed each test and the date(s) the tests were performed, as well as = the=20 date and signature of a second person showing that the original records = have=20 been reviewed for accuracy, completeness, and compliance with = established=20 standards.

2. Failure of your investigations of out-of-specification (OOS) = results to=20 determine if corrections or preventive actions are needed.

During the inspection, it was noted that at least 7 OOS results were = found=20 and confirmed by your firm. Your firm failed to continue its = investigation of=20 the OOS results outside of the laboratory in order to determine the = cause of the=20 results. Your firm promised corrective action, however, no documentation = and/or=20 written commitment was provided.

Any OOS result obtained should be investigated and documented = according to a=20 procedure. This procedure should include analysis of the data, = assessment of the=20 extent and cause of the problem, allocation of the tasks for corrective = actions,=20 and conclusions. Any resampling or retesting after OOS results should be = performed according to a documented procedure.

Written procedures should be established and followed for = investigating=20 deviations or the failure of a batch of intermediate or API to meet=20 specifications. The investigation should extend to other batches that = may have=20 been associated with the specific failure or deviation.

3. Failure to have a validated and secure computerized system. = Additionally,=20 there were no written protocols to assign levels of responsibilities for = the=20 system.

It was noted that the [redacted] instrument = model=20 [redacted] used for the analysis of [redacted] = failed=20 to have password control for the analysts and the supervisor. It was = observed=20 that the data stored on the computer can be deleted, removed, = transferred,=20 renamed or altered.

While your firm's management stated that they would like to implement = certain=20 improvements in order to establish a security system, no documentation = or=20 commitment has been provided.

Please note that computerized systems should have sufficient controls = to=20 prevent unauthorized access or changes to data. There should be controls = to=20 prevent data omissions and assure back-up. There should be a record of = any data=20 change made, the previous entry, who made the change, and when the = change was=20 made.

The CGMP deviations identified above or on the FDA-483 issued to your = firm=20 are not to be considered an all-inclusive list of the deficiencies at = your=20 facility. If you wish to continue to ship your products to the United = States, it=20 is the responsibility of your firm to assure compliance with all U.S. = standards=20 for Current Good Manufacturing Practices.

During the inspection, your firm refused to provide copies of = production=20 records, laboratory records, and written procedures requested by the FDA = Investigator and Analyst for their later review. Your refusal to provide = documents hinders FDA's ability to perform an inspection an d determine = your=20 firm's compliance with CGMP requirements. Thus, FDA considers your = refusal to=20 provide documents as a refusal to allow inspection. APIs manufactured by = your=20 firm may be refused entry into the U.S. pursuant to Section 801(a)(3) of = the=20 FD&C Act in that the methods and controls used in their manufacture = do not=20 appear to conform to current good manufacturing practice within the = meaning of=20 Section 501(a)(2)(B) of the FD&C Act, if documents necessary for an=20 inspection and CGMP assessment are not provided.

We recommend that you conduct a complete and extensive evaluation of = your=20 facility to help ensure that APIs meet the quality and purity = characteristics=20 that they purport, or are represented, to possess. Please note that a = guidance=20 document entitled "Q7A Good Manufacturing Practice Guidance of Active=20 Pharmaceutical Ingredients" (ICH CGMP Guidance), prepared under the = auspices of=20 the International Conference on Harmonization of Technical Requirements = for=20 Registration of Pharmaceuticals for Human Use (ICH), describes CGMP for=20 manufacturing of APIs. The guidance, adopted by the FDA on September 25, = 2001,=20 is intended to help ensure that all APIs meet the standards for quality = and=20 purity that they purport or are represented to possess. Although the ICH = CGMP=20 Guidance does not impose requirements, FDA considers its = recommendations, as=20 well as alternatives intended to accomplish the same goals and provide = an=20 equivalent level of quality assurance, in determining whether a firm's = APIs have=20 been manufactured, processed, packed, and held according to CGMP under = Section=20 501(a)(2)(B) of the Act. To obtain the ICH CGMP Guidance for your = reference,=20 refer to the following website: http://www.fda.gov/= cder/guidance/4286fnl.htm

Please respond to this letter within 30 days of receipt. Your = response should=20 include documentation with translation in English to address the = deficiencies=20 cited as well as copies of procedures. Please identify your response = with FEI=20 #3002808375. Until all corrections have been completed and FDA can = confirm your=20 firm's compliance with CGMPs, this office will recommend disapproval of = any new=20 applications or supplements listing your firm as a manufacturer of APIs. =

Please contact Marybet Lopez, Compliance Officer, at the address and=20 telephone numbers shown below, if you have any questions, further = information,=20 or further proposals regarding this letter.

U.S. Food & Drug Administration
Center for Drug Evaluation = and=20 Research, HFD-325
11919 Rockville Pike
Rockville, MD 20852 =
Tel:=20 (301) 827-9004
FAX (301) 827-8909

To schedule a re-inspection of your facility, after corrections have = been=20 completed and your firm is in compliance with CGMP requirements, send = your=20 request to: Director, Division of Field Investigations HFC 130, 5600 = Fisher's=20 Lane, Rockville, MD 20857. You can also contact that office by telephone = at=20 (301) 827-5655 or by fax at (301) 443-6919.

Sincerely,

/S/

Richard L. Friedinan
Director
Division of Manufacturing and = Product=20 Quality
Office of Compliance
Center for Drug Evaluation and = Research=20

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