FDA 483 - Lupin Limited - June 16, 2017

The FDA Form 483 details observations from an inspection, highlighting failures in quality control and manufacturing processes.

A primary concern is the firm's failure to thoroughly review unexplained discrepancies, with 87% of Out-of-Specification (OOS) results from 2015-2017 being invalidated. Specific examples include OOS Investigations OOS/E/16/IN3/SS/002 and OOS/E/16/IN3/SS/018, both concerning content uniformity failures for exhibit batches. In these cases, conclusions were assumed, not scientifically evaluated, and initial results were invalidated through retesting without investigating potential manufacturing process issues. Similar issues were noted in OOS/E/16/IN3/SS/013, OOS/E/16/IN3/SS/019, OOS/E/16/IN3/SS/014, and OOS/E/16/IN3/SS/021.

Control procedures are deficient, as in-process tests for critical quality attributes (CQAs) are not included in specifications or batch records. Sampling plans for in-process materials lack scientific justification to ensure representativeness, particularly for processes involving multiple significant events like bulk suspension.

Acceptance criteria for quality control testing are inadequate. The firm lacks scientific justification for weight limits used in the online Check Weigher (