FDA EIR - Patheon Manufacturing Services LLC - September 12, 2014

An FDA surveillance inspection of Patheon Manufacturing Services, LLC, a sterile biologic drug product manufacturer in Greenville, NC, took place from September 9 to September 12, 2014. The inspection focused on the firm's small volume parenteral sterile biologic product operations, covering Quality, Laboratory, Production, and Packaging and Labeling Systems. Four significant observations were cited on an FDA Form 483, indicating deviations from current Good Manufacturing Practices (cGMP), specifically under 21 CFR Part 211.

The main issues included a disinfectant efficacy study that did not accurately reflect how disinfectants are actually used in sterile production facilities. There were also concerns regarding the inadequate sanitization of equipment and materials, such as thermal paper, necessary to prevent contamination. Furthermore, the firm's environmental monitoring trend analysis procedure was found to be deficient, lacking clear definitions for negative trends and proper data interpretation. Lastly, sterility testing procedures were not followed, as a critical growth medium used for testing was deemed unsuitable, failing compendial requirements.

Patheon management committed to providing a written response to the FDA within 15 business days, outlining their proposed corrective actions for the identified deficiencies. The FDA emphasized that failure to address these serious conditions could result in further regulatory action.