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.