Vital Laboratories failed to report production deviations, perform proper product reviews or take needed corrective actions at its Gujarat, India, facility, the FDA said in a warning letter.
The FDA inspected the facility in April and observed numerous GMP violations. The facility, investigators said, did not perform required in-process tests described in batch records.
Batch production records also left out signature fields documenting which employees performed, supervised and checked each step in the process. The company claimed it revised the record to include a space for verifiers and operators to sign, and that supervisors signed on behalf of operators because the operators’ hands were dirty.
The company also failed to investigate out-of-specification analytical test results, and used the results to assign an expiration date. Investigators also found deficiencies in the company’s annual product reviews. Stability data from its 2016 review for one of its APIs contained data identical to that of the 2015 review, as well as stability data that could not have been generated at the times in the report.
The agency called on the company to conduct a retrospective review of all annual product reviews over the past three years and for a table summarizing the findings.