CGMP Violations at Teva Godollo, Hungary, Plant

Significant violations of current good manufacturing practice regulations for finished pharmaceuticals were found during a 1/21-1/29 FDA inspection at Teva’s drug manufacturing facility in Godollo, Hungary. A 10/13 Warning Letter says that specific violations included: 

•          failing 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;
•          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
•          failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
•          failing 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;
•          failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards;
•          failing 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; and
•          failing to follow adequate written procedures for preparing master production and control records to assure uniformity from batch to batch.

The letter says the firm’s responses to the inspection observations were inadequate. FDA recommended that a consultant assist the company in meeting CGMP requirements. The agency also said that the quality system at the plan “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” It acknowledged Teva’s use of a consultant to audit the operation and assist in meeting FDA requirements and called for (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on drug quality; and (3) a management strategy for the firm including details of a global corrective action and preventive action plan.

FDA placed the firm on Import Alert on 5/27. Teva was told to respond with steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.