FDA 483 - Indoco Remedies Limited - September 04, 2016

During an inspection conducted from August 31 to September 4, 2016, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Indoco Remedies Limited, a drug manufacturer located in Verna, Goa, India. The document outlined significant observations regarding the company's compliance with manufacturing regulations.

Key issues included a deficient quality system, specifically the failure to thoroughly investigate approximately 459 complaints of leaking or empty sterile product bottles, with investigations not extending to all potentially affected batches or products. The quality control unit also lacked adequate authority to approve or reject products, notably concerning stability batches with identified leachables of unknown toxicity. Furthermore, procedural deficiencies in sampling techniques led to recurring Out-of-Specification results without proper corrective actions.

Observations related to the production system highlighted inadequate procedures to prevent microbiological contamination, including insufficient validation of gowning sterilization cycles and a lack of qualification for personnel performing visual inspections for small particles in sterile injectables. Facilities and equipment issues included unsuitable design and placement of equipment, creating contamination risks in aseptic areas. Finally, the company failed to submit required Field Alert Reports for the widespread complaints of leaking sterile products.

These observations indicate potential deviations from established good manufacturing practices. Indoco Remedies Limited is required to respond to these findings with comprehensive corrective and preventive actions to ensure product quality and patient safety.