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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