FDA 483 - Apicore Pharmaceuticals Private Ltd - May 05, 2023

During an inspection conducted from April 27 to May 5, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Apicore Pharmaceuticals Private Ltd, a manufacturer located in Vadodara, Gujarat, India. The inspection revealed two primary observations concerning the company's manufacturing practices. Firstly, the FDA noted deficiencies in the validation of aseptic processes designed to prevent microbiological contamination of sterile drug products. Specifically, a media fill study simulating sterile Active Pharmaceutical Ingredient (API) manufacturing failed due to microbial growth, but the firm performed only one repeat media fill for re-validation, instead of the required three consecutive studies. Additionally, the disinfectant efficacy study method employed by Apicore was inconsistent with its routine disinfection procedures. Secondly, the inspection identified issues with the routine calibration of electronic equipment. An analytical balance used in the Quality Control chemistry laboratory was not calibrated across its full operational weight range, with its verification protocol omitting the lower weight range. These observations, issued under the regulatory framework of an FDA 483, indicate potential deviations from Current Good Manufacturing Practices. Apicore Pharmaceuticals Private Ltd is required to thoroughly address these findings and implement comprehensive corrective and preventive actions to ensure compliance and the quality of its drug products.