FDA EIR - Pharmaceutics International Inc - November 14, 2022

An FDA "for cause" inspection of Pharmaceutics International Inc. (Pii), a contract development and manufacturing organization (CDMO) based in Hunt Valley, MD, was conducted between May 10 and November 14, 2022. This comprehensive inspection, initiated by CDER's Office of Manufacturing Quality, operated under regulatory frameworks including drug manufacturing, ANDA pre-approval, and NDA field alert compliance programs. Pii, which manufactures sterile and non-sterile human and animal drugs, experienced disruptions during the inspection, including personnel COVID-19 cases and a ransomware attack that halted production. The inspection meticulously reviewed Pii's quality, facilities, equipment, materials, laboratory, and production systems, and assessed the company's implementation of corrections from a previous 2021 inspection. At the conclusion, a three-item FDA 483 "Inspectional Observations" was issued to company leadership. The primary violations included an inadequate cleaning validation process that failed to incorporate bioburden considerations, a lack of comprehensive vendor qualification, specifically regarding the full bioburden testing of supplier Certificates of Analysis, and a failure to properly qualify temperature-controlled storage units. Pii is now required to formally address these observations with detailed corrective and preventive actions to ensure adherence to current Good Manufacturing Practices.