FDA EIR - Patheon Manufacturing Services LLC - May 17, 2019

An FDA routine current Good Manufacturing Practices (CGMP) surveillance inspection of Patheon Manufacturing Services, LLC (doing business as Thermo Fisher Scientific) was conducted in Greenville, NC, from May 13-17, 2019. This inspection, carried out under FDA Compliance Policy Guidance Manuals for drug manufacturing, sterile drug processes, and NDA field alert reports, aimed to assess the firm's adherence to regulatory standards as a manufacturer of sterile and non-sterile human and animal drug products.

Key observations included several deviations from established procedures. The firm was found to have issues with documentation practices, specifically where initials for interventions in media fill records were recorded by individuals not performing the activity, violating their own Good Documentation Practices. Additionally, there were significant delays in completing complaint investigations, with over 30% of investigations between June 2017 and April 2019 extending past their internal due dates. In the microbiology laboratory, inconsistencies were noted in the Cleaning Sample Submission Log, including incomplete entries and improper markings, contravening documentation protocols.

In response to these findings, Patheon Manufacturing Services, LLC committed to specific corrective actions. They suspended all future media fill activities until a compliant system for documenting interventions could be developed. The firm also acknowledged the complaint investigation delays and implemented a new tracking log to improve completion rates. Furthermore, new procedures and a revised Cleaning Sample Submission Log were introduced in the microbiology lab, with staff receiving retraining on proper documentation. Although no Form FDA 483 was issued, management was reminded of their ongoing responsibility for compliance to prevent potential legal sanctions.