FDA Flags Vital Laboratories for Inadequate Storage, Training

The FDA cited a Vital Laboratories facility in Gujarat, India over failure to investigate out of specification results, conditions for material storage, and employee training.

The agency issued the Form 483 following an April inspection of the facility, listing numerous compliance issues, including failure to investigate discrepancies in product stability testing.

The investigators also found inadequate quality unit oversight to ensure production and control records were complete.

The company also failed to include signature fields in the batch production records. The records also lacked initials or signatures of a second person to indicate the data entries had been reviewed for accuracy.