FDA 483 - Felix Generics Private Limited - August 27, 2024

Felix Generics Private Limited, a veterinary drug manufacturer in Dhar Madhya, Uttar Pradesh, India, underwent an FDA inspection from August 21-27, 2024. The inspection resulted in an FDA 483 report, citing significant deviations from regulatory requirements, indicating a lack of adherence to Good Manufacturing Practices. Key observations included inadequate laboratory controls, specifically the absence of defined procedures for handling High-Performance Liquid Chromatography (HPLC) warning messages and their integration into corrective actions or equipment qualifications. The firm also failed to establish statistically significant sampling plans for in-process and finished product analyses, potentially compromising product quality. Deficiencies were noted in equipment cleaning and maintenance procedures, lacking specific parameters like cleaning agents and contact times, which could lead to cross-contamination. Furthermore, the company failed to thoroughly investigate discrepancies, including a complaint involving a dog's death, and did not consistently initiate corrective and preventive actions (CAPAs) for various investigations. Critical lapses in data integrity were observed within the Quality Control Unit, including inadequate document control with unauthorized access to reproduction equipment and loose security of production keys and unattended laptops, compromising the reliability of manufacturing and laboratory records. Felix Generics is expected to address these observations to ensure compliance with federal regulations.