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

This FDA Form 483 was issued to Apicore Pharmaceuticals Private Ltd, a manufacturer located in Vadodara, Gujarat, India, following an inspection from April 27 to May 5, 2023. The inspection revealed two observations.

Observation 1 details inadequate validation of aseptic processes designed to prevent microbiological contamination of sterile drug products. Specifically, a media fill study (MF/CPMD/22/04/01) conducted in May 2021 for sterile API manufacturing failed, recovering multiple CFUs, including spore-forming bacteria (Bacillus subtilis, Bacillus pumilus, Bacillus oceanisediminis, Bacillus megaterium). Instead of performing three consecutive media fills for re-validation, the firm conducted only one repeat media fill. Additionally, the disinfectant efficacy study (Protocol #s ACP-22-015-00) used a method (pipetting disinfectant over dried culture) that differed from the routine disinfection procedure (spreading disinfectant with a mop or lint-free cloth per APV-SOP-MFG253).

Observation 2 notes that routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance. Specifically, analytical balance QCE # 684, used in the QC chemistry laboratory for weighing test samples with a range of 20 mg to 200 g, had its verification performed only for the 50 mg to 20