FDA 483 - Intas Pharmaceuticals Limited - May 12, 2023

This FDA Form 483 document details multiple observations from an inspection, indicating significant deficiencies in the facility's quality control and manufacturing processes.

**Key Observations:**

* **Batch Production and Control Records:** Incomplete information in batch records and identical visual inspection records for multiple operators were noted. * **Process Controls:** Inadequate controls for tablet compression and a failure to thoroughly review unexplained discrepancies were identified. * **Written Procedures:** The firm lacked adequate written procedures for production and process controls to ensure drug product identity, strength, purity, and quality. * **Aseptic Processing:** Deficiencies included inadequate validation of aseptic and sterilization processes, insufficient cleaning/disinfection systems, and inadequate environmental monitoring in aseptic areas. * **Computer Systems:** Controls over computer systems were insufficient to ensure changes to master records were made only by authorized personnel. * **Equipment Maintenance:** Routine checking of automatic, mechanical, and electronic equipment was not performed per a written program. Equipment and utensils were not maintained at appropriate intervals, and equipment design was not appropriate for its intended use. * **Quality Control Unit:** Responsibilities and procedures of the quality control unit were not fully followed. * **Annual Quality Standards Review:** Procedures for annual quality standards evaluation were deficient, lacking review of a representative number of approved and rejected batches. * **Microbiological Contamination:** Procedures to prevent objectionable microorganisms in non-sterile drug products were inadequate. *