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Wednesday, October 26, 2016

The U.S. Food and Drug Administration (FDA) warning letter to Teva Pharmaceutical Works Private Limited


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The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Teva Pharmaceutical Works Pvt. Ltd. at 2100 Godollo, Tancsics Mihaly ut 82, Godollo, Hungary, from January 21 to 29, 2016. 
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. 
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). 
We reviewed your firm’s February 22, 2016, response in detail and acknowledge receipt of your subsequent correspondence.
Our investigators observed specific violations including, but not limited to, the following consolidated violations for more details Click Here

1.    Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. (21 CFR 211.192)

You did not adequately investigate media fill and sterility test failures. These failures indicate that there is a lack of adequate sterility assurance in your manufacturing facility.

a.    Media Fills

b.    Sterility Test Positive Investigations
·         . 
2.    Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. (21 CFR 211.113(b))

a.    Poor Aseptic Behavior

b.    Mechanical Failure During Media Fill

3.    Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas. (21 CFR 211.42(c)(10)(iv))


4.    Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. (21 CFR 211.160(b))

5.    Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. (21 CFR 211.194(a))


6.    Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. (21 CFR 211.68(b))


7.    Your firm failed to follow adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch. (21 CFR 211.186(a)) 


CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, we strongly recommend that your consultant, who should be qualified as set forth in 21 CFR 211.34, assist your firm in meeting CGMP requirements. Your consultant should provide a thorough assessment of your entire operation to identify contamination hazards, assist in remediation of sterility assurance in your facility, improve your quality system, and certify readiness. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.

Additional Guidance on Aseptic Processing
See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing, online at http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070342.pdf.

Data Integrity Remediation
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements.





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