FDA EIR - Patheon Manufacturing Services LLC - December 17, 2015

An FDA pre-approval inspection of Patheon Manufacturing Services, LLC in Greenville, NC, occurred from December 14-17, 2015. The inspection, focusing on the firm's new Animal Health drug product facility for a non-sterile liquid product, was conducted under established animal drug pre-approval and drug manufacturing compliance programs. The inspection revealed three primary issues documented on a Form FDA 483. Firstly, the company did not consistently determine and document actual and theoretical yield percentages during drug product packaging, resulting in high, undocumented reject rates (up to 32.5%) without necessary investigations, violating regulations concerning batch production and control. Secondly, drug products were not stored under appropriate temperature and humidity, as the Animal Health finished product warehouse lacked proper environmental monitoring. Thirdly, established laboratory control mechanisms were not consistently followed or documented, particularly regarding the removal and logging of expired reagents. Management acknowledged these issues, committing to install environmental monitoring, develop a corrective action plan for laboratory deficiencies, and formally respond to the packaging yield observation. The FDA underscored the firm's obligation to maintain compliance and cautioned about potential legal actions if corrective measures are not voluntarily implemented.