FDA 483 - Apitoria Pharma Private Limited - August 12, 2021

This FDA Form 483 details multiple observations from an inspection. The facility failed to adequately qualify critical material suppliers, specifically for Key Starting Materials (KSMs) used in REDACTED and REDACTED products. For REDACTED, manufacturing ceased in February 2016 and resumed in February 2021, but no justification was provided for the KSM supplier's quality and purity, or its impact on the Active Pharmaceutical Ingredient (API). For REDACTED, a new KSM vendor was not adequately qualified prior to process validation initiated December 6th, 2019, failing to ensure consistent quality and adherence to the "Qualification & Evaluation of External Vendor for Raw Material" procedure, section 5.8.2.

Additionally, sampling plans for raw materials and intermediates were deemed inadequate, lacking scientific justification for representativeness. Components were not tested and released prior to use, with the Quality Control (QC) unit failing to test for impurities in REDACTED prior to REDACTED process validation batches (February 6th to May 28th, 2021). Proposed manufacturing process changes were not adequately evaluated for potential product quality impact.

QC investigations into unexplained discrepancies were not scientifically sound, failing to determine root causes and implement adequate corrective and preventative actions. Examples include complaint investigations (MC-CAD-002696, MC-CAD-003725, MC-CAD-0