FDA EIR - Pharmaceutics International, Inc. - July 10, 2020

An FDA Pre-Approval Inspection of Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization, was conducted from July 6-10, 2020. The inspection at their Cockeysville, Maryland facility evaluated the firm's quality, production, facilities and equipment, materials, and laboratory control systems for readiness to manufacture a new sterile drug product, in accordance with Current Good Manufacturing Practices (cGMP) under 21 CFR 210/211.

At its conclusion, a five-item Form FDA-483 was issued to President and CEO, Dr. Kurt R. Nielsen, highlighting several deficiencies. Main issues included equipment used in manufacturing not being of appropriate design and size, particularly regarding aseptic processing where operators interacted with damaged curtain enclosures around critical areas. The firm also failed to adequately maintain equipment and provide sufficient controls against microorganisms. Furthermore, building construction was deemed unsuitable for proper cleaning and operations, evidenced by debris and insects in cleanroom light fixtures, and structural vulnerabilities in support areas. Finally, procedures to prevent microbiological contamination of sterile drug products were not fully established, including a lack of purity testing for a critical utility at its point of use. Dr. Nielsen committed to submitting a written response to the agency within 15 business days.