Teva Pharmaceuticals just received a “Warning Letter” from the U.S. Food and Drug Administration (FDA) due to the agency’s Current Good Manufacturing Practices (CGMP) inspection of Teva’s Gödöllő, Hungary’s manufacturing facility. Teva was also placed on Import Alert 66-40 on May 27, 2016.
The agency’s warning letter notes deficiencies in how manufacturing operations, laboratory controls, and Teva’s data integrity program are handled at the Gödöllő plant, according to Reuters.
The agency’s letter, addressed to Mr. Erez Vigodman, president and CEO of Teva Pharmaceutical Works Pvt. Ltd., discusses deficiencies in manufacturing operations and laboratory controls, as well as in Teva’s data integrity program. The Gödöllő plant inspection was conducted from January 21, 2016 through January 29, 2016.
The warning letter summarized what the agency described as significant violations of CGMP “regulations for finished pharmaceuticals.” According to the FDA, because Teva’s Gödöllő plant’s “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP,” its drug products have been deemed adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also indicated that it reviewed Teva’s February 22, 2016 response “in detail and acknowledge receipt of” Teva’s follow-up correspondence. The FDA investigators found specific violations that included that Teva failed to:
- thoroughly investigate unexplained discrepancies/failures of a batch or its components to meet specifications, regardless of if the batch was distributed;
- establish and follow appropriate written procedures meant to prevent microbiological contamination of purportedly sterile drug products, including validation of all aseptic (free from contamination caused by harmful bacteria, viruses, or other microorganisms) and sterilization processes;
- establish an adequate system for monitoring environmental conditions in aseptic processing areas and laboratory controls, including scientifically sound and appropriate specifications, standards, sampling plans, and test procedures meant to ensure components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- ensure laboratory records include complete testing data to ensure compliance with established specifications and standards;
- exercise appropriate controls over computer or related systems to ensure only authorized personnel institute changes in master production, control records, or other records; and
- follow appropriate written procedures for master production preparation and control records meant to ensure batch uniformity.
Violations cited by the FDA are not all-inclusive and the FDA noted that failure to correct the violations may result in the agency continuing to refuse admission of articles manufactured at Teva Pharmaceutical Works Private Limited Company into the United States under the FD&C Act. Articles may be subject to refusal of admission if the methods and controls used in their manufacture do not appear to conform to CGMP as described under the Act. Teva must respond to the FDA within 15 working days of the agency’s “Warning Letter.”