FDA EIR - Patheon Manufacturing Services LLC - November 12, 2021

An FDA pre-approval inspection of Patheon Manufacturing Services LLC (doing business as Thermo Fisher Scientific) in Greenville, NC, was conducted from November 8 to November 12, 2021. This directed assessment, under the Office of Pharmaceutical Quality Operations, focused on evaluating the firm's readiness for blister pack packaging, stability storage, and associated testing for a new product application for sterile and non-sterile human and animal drugs. The inspection was conducted in accordance with Compliance Policy Guidance Manual 7346.832, Pre-Approval Inspections.

Crucially, the inspection concluded without the issuance of an FDA Form 483, meaning no objectionable conditions or deficiencies were observed. No verbal observations were discussed, as any initial questions raised during the review were satisfactorily resolved on-site. The investigator found the firm's practices satisfactory and indicated a recommendation for approval of their packaging and stability operations for the application product. This positive outcome reflects the company's adherence to regulatory expectations during this specific pre-approval assessment.