Indian API Manufacturer Called Out for Numerous Violations
The FDA cited Reliance Life Sciences for a long list of deficiencies observed during an inspection of the API manufacturer’s facility in Navi Mumbai in December.
The investigator listed 18 violations in a Form 483, including batch failures, unexplained discrepancies, quality unit shortcomings and a lack of vendor qualification.
For example, the firm failed to reject material that was determined to be out-of-specification and used it in the manufacturing of a product. It also determined the root cause behind several OOS instances without providing any scientific rationale.