FDA EIR - Pharmaceutics International Inc - July 10, 2020

A recent FDA Pre-Approval Inspection of Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization in Hunt Valley, MD, was conducted from July 6 to July 10, 2020. This inspection, focusing on readiness for commercial manufacturing under a New Drug Application (NDA), identified a significant deficiency related to the company's vendor qualification program. The primary violation, documented in a one-item FDA Form 483, highlighted the Quality Unit's failure to adequately establish the reliability of component suppliers' analyses through periodic analytical evaluations. Specifically, Pii did not perform full testing to qualify its supplier for Nitrogen, NF, an excipient used in sterile manufacturing, relying instead on identification testing and a Certificate of Analysis. The company's internal procedures actually required full testing for such materials. Additionally, Pii failed to properly validate its supplier for Allegro Single Use Systems, critical for compounding and dispensing the drug product, again accepting components based solely on the supplier’s Certificate of Quality without conducting full testing or establishing internal specifications. These findings indicate non-conformance with current Good Manufacturing Practices (cGMP), specifically 21 CFR 211.84(d)(2) concerning the testing and approval or rejection of components and drug product containers and closures. Pii management committed to providing a written response to the FDA-483 observations within 15 business days, outlining corrective and preventive actions to address the identified vendor qualification deficiencies.