AptaPharma Inc. – FDA EIR, Sep 25, 2019

An FDA surveillance inspection of AptaPharma Inc., a contract manufacturer of over-the-counter and prescription drugs, was conducted from September 9 to September 25, 2019. The inspection focused on Pre-approval and Good Manufacturing Practices (GMP) for drug products, including liquid and oral suspension formulations, under regulatory guidelines CP7346.832 and CP7356.002. The inspection resulted in a 2-point FDA-483 observation. The primary issues included: (1) AptaPharma's failure to adhere to established specifications for Sildenafil for Oral Suspension (ANDA 213041), specifically regarding incorrect dissolution testing parameters, and inadequate internal controls to detect this discrepancy or assess its impact during change control. (2) The company lacked sufficient manufacturing capacity for Oseltamivir Phosphate for oral suspension (ANDA 212858), as essential blending equipment was not on-site or qualified for use, and packaging equipment qualification was incomplete. Additionally, verbal concerns were raised regarding the cleanliness of manufacturing areas, the absence of historical trend analysis in investigations, incomplete impact analysis documentation, inconsistent temperature monitoring for storage refrigerators, and deficiencies in GMP training for some staff. In response, AptaPharma management committed to several corrective actions, including initiating laboratory investigations, revising test methods, retesting products, updating analytical documentation and change control procedures, and ensuring the qualification of necessary equipment by November 7, 2019. Other promised actions included installing a stainless-steel plate above a manufacturing tank and ensuring consistent temperature monitoring.