FDA 483 - Ipca Laboratories Limited - June 13, 2023

Ipca Laboratories Ltd. received a Form 483 citing significant deficiencies in their API manufacturing operations. Observations included inadequate investigations into OOS results, deviations, and market complaints, as well as failures by the Quality Unit to take appropriate actions for failing API batches. The firm also lacked scientifically sound procedures for process validation, analytical testing, and equipment cleaning, alongside issues with batch certification and record keeping.