FDA 483 - InvaGen Pharmaceuticals, Inc. - September 19, 2023

Invagen Pharmaceuticals, Inc., located in Central Islip, NY, was inspected by the FDA from September 11 to September 19, 2023. This inspection led to a Form FDA 483, detailing multiple observations concerning their manufacturing operations and quality systems.

Significant issues included the Quality Assurance Unit's failure to review and approve written Good Manufacturing Practice (GMP) documents, especially those predating CIPLA's acquisition of the facility. The firm also lacked adequate bulk hold time studies for in-process materials, resulting in drug product batches exceeding manufacturing time limits without scientific justification or stability testing.

Further observations noted deficiencies in material control, specifically the absence of procedures to verify the count of incoming printed drug product labels. Equipment cleanliness was also a concern, with soiled sieve screens and tablet dies observed in the production area. Lastly, the Quality Control unit's change control procedures were found inadequate, as they lacked required due dates, leading to a backlog of unresolved change controls from both 2022 and 2023.

These findings highlight deviations from regulatory expectations under the Federal Food, Drug, and Cosmetic Act, implying a need for Invagen Pharmaceuticals to implement robust corrective actions to ensure compliance with GMP standards.