FDA 483 - Ipca Laboratories Limited - June 13, 2023

This FDA Form 483 document outlines several significant observations made during an inspection. The facility's Quality Unit is cited for failing to adequately investigate the root cause of out-of-specification (OOS) batches of intermediate or Active Pharmaceutical Ingredient (API), even when distributed. Furthermore, the Quality Unit did not take sufficient action regarding failing API batches sold domestically and internationally.

Reworked API is not appropriately evaluated, tested, or stability-tested to demonstrate equivalent quality to product from the original process. The firm failed to establish optimal processing conditions to ensure consistent critical quality attributes for APIs. There is a lack of adequate oversight and control over drug manufacturing, including managing risks and ensuring the safety of materials used.

Specifications and test procedures for raw materials and API are not scientifically sound or appropriate. Laboratory tests for batch conformance are deficient. The Quality Unit failed to ensure all deviations are reported on batch certifications by third-party consultants. Calibration of Micro Lab equipment is deficient, and the suitability determination of secondary reference standards against primary standards is inadequate. Finally, the firm failed to establish and follow written procedures to prevent microbiological contamination of sterile drug products.