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.
In addition, the firm did not follow one of its OOS protocols, a procedure for experimental design that called for using a second analyst in OOS investigations where no assignable cause or probable cause is identified or suspected.
The firm’s quality unit failed to follow all procedures assigned to it. Multiple critical and non-critical raw material suppliers used for the firm’s API manufacturing were not qualified, and quality agreements were not established with all suppliers.
The agency also noted problems with the firm’s internal audit process. Although the facility’s senior manager for quality assurance said a deviation must be raised for auditors in training if they do not meet the internal audit deadline, the practice was not listed in the standard operating procedures.
Employees assigned to process and hold API finished material were not properly trained, the investigator noted. For example, one of the firm’s deputy managers had not been adequately trained for the lead auditor role he held during an internal audit of the quality assurance department in September 2016.