| Public Health Service Food and Drug Administration |
| 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 Telephone: (787) 474-9500 Fax: (787) 729-6658 |
Department of Health and Human Services
October 13, 2011
WARNING LETTER
12-SJN-WL-01
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
RETURN RECEIPT REQUESTED
Mr. Robert J. Coury
Chairman, President, and CEO
Mylan Laboratories, Inc.
1500 Corporate Drive, Suite 400
Canonsburg, PA 15317
Dear Mr. Coury:
The United States Food and Drug Administration (FDA) conducted an inspection of your pharmaceutical manufacturing facility located at Lot No. 24-B, Road #156 Caguas, Puerto Rico, from 01/24/2011 to 02/24/2011. During the inspection, we identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food Drug and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We have reviewed your firm’s response of 03/14/2011, and note that it lacks sufficient corrective actions.
Specific violations observed during the inspection include, but are not limited, to the following:
1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product prior to release [21 C.F.R. § 211.165(a)].
For example, your firm failed to complete the content uniformity (CU) test required by the United States Pharmacopeia (USP). As documented in investigation (b)(4), after Loperamide Hydrochloride Capsules USP 2mg (lot 3021292) failed to conform to the acceptance criteria of less than or equal to L1% =15% (Result 19.7%) for the (b)(4) as required in the acceptance criteria of USP Chapter ‘<905> Uniformity of Dosage Units’ CU test.
Your firm’s response failed to include the scientific rationale (e.g., statistical justification) for not completing the CU test.
2. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192].
For example, in several investigations your firm attributed out-of-specification (OOS) results to assignable causes (i.e., (b)(4)), but failed to include sufficient supporting evidence to invalidate the initial data.
Your firm’s response failed to include the scientific rationale used to invalidate the OOS results, including adequate data to support the assignable causes and to justify that the initial OOS results did not reflect the quality of the batch.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facilities. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations detailed in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
Within (15) fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your written reply to these concerns should be directed to: Food and Drug Administration, Attention: Carlos A. Medina, Compliance Officer, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at (787)474-9538.
Sincerely,
/S/
Maridalia Torres
District Director
San Juan District
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