Glenmark Pharmaceuticals Limited – FDA 483, Nov 11, 2017

The FDA Form 483 details numerous deficiencies at an unnamed facility. Key issues include a failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, OOS investigations (e.g., 05/OOS15004) lacked proper root cause analysis, with failures attributed to unverified sample preparation errors or ruptured septa, supported by undated photographs not electronically archived.

Interview records during OOS investigations were not contemporaneously recorded, and questions were leading. There are no written procedures for production and process controls to assure drug product quality. Hold time studies were conducted with batch sizes not representative of commercial production, and samples were not tested in a timely manner, compromising data integrity. Batch Production Records lack hold time calculations, and procedural controls for timely hold time studies are absent.

The facility has not conducted Stage III Continuous Process Verification (CPV) for most commercial products, with no documented rationale for product selection or future plans. Complaint records are deficient, lacking investigation findings and follow-up. A significant number of complaints for product grittiness (Cream USP, batch ) were linked to extended bulk hold times, but a comprehensive investigation into this impact was not performed, and returned samples were not chemically evaluated. Similarly, products exposed to out-of-specification temperatures during shipping (e.g., and Cream USP) were not evaluated for quality impact, despite related consumer complaints.

Annual Product Quality Review (APQR) data