FDA 483 - Alembic Pharmaceuticals Limited - August 30, 2022

An FDA inspection conducted at Karakhadi, Tal Padra from August 18 to August 30, 2022, revealed significant observations related to manufacturing practices. The inspection, documented in an FDA Form 483, highlighted two primary areas of concern. Firstly, deficiencies were noted in aseptic processing areas, specifically concerning the air supply, which was not adequately filtered through high-efficiency particulate air (HEPA) filters under positive pressure. Furthermore, airflow visualization studies used to qualify aseptic filling operations were found insufficient, failing to provide adequate visualization of airflow patterns in critical areas for sterile drug product filling. Secondly, the inspection identified that deviations from written production and process control procedures were not consistently recorded and justified. A review of six deviation investigations revealed that four lacked appropriate actions to prevent reoccurrence. Specific examples included a HEPA filter failure where the investigation did not address preventative maintenance or expected lifespan, temperature excursions in an incubator without discussion of preventative maintenance for sensors, a pump failure investigation that omitted preventative maintenance considerations, and an inadequate cleaning validation study where product solubility was not evaluated, and preventative actions were not discussed. These observations indicate potential non-compliance with Current Good Manufacturing Practices (CGMP) and necessitate a thorough review by Karakhadi, Tal Padra. The company is expected to implement robust corrective and preventive actions to address these deficiencies, enhance quality systems, and ensure the ongoing safety and efficacy of their drug products.