FDA EIR - Patheon Manufacturing Services LLC - August 04, 2022

An FDA Level 2-GMP inspection of Patheon Manufacturing Services LLC, a contract biological product manufacturer in Greenville, NC, was conducted from July 26 to August 4, 2022. The inspection, carried out under CPGM 7345.848 for biological drug products, resulted in an FDA Form 483 with four main observations. Key violations included instances of improper aseptic technique during sterile product filling and an unsuitable sterile suite design where limited space challenged proper aseptic operations. Furthermore, the company's investigations were deemed incomplete: an inquiry into a HEPA filter failure did not assess its impact on previously manufactured batches, and investigations into foreign particles in product complaints lacked identification of the material and assessment of its origin within the facility. Investigations into multiple (b)(4) test failures on a filling line were also found to be incomplete. In response, management committed to providing a written response, updating relevant procedures (e.g., hand sanitization and complaint handling), and implementing corrective and preventative actions, including a preventative maintenance schedule for critical equipment.