FDA EIR - Patheon Manufacturing Services LLC - April 20, 2017

An FDA Pre-Approval Inspection of Patheon Manufacturing Services, LLC, in Greenville, NC, was conducted from April 17-20, 2017. The inspection evaluated the facility's manufacturing processes for a new drug product (SHP465) under NDA 22063, specifically assessing compliance with the Food, Drug, and Cosmetic Act and 21 CFR 211 (Good Manufacturing Practices).

Although no official FDA Form 483 was issued, two verbal observations were noted: inadequate control of labeling material and inappropriate control of Active Pharmaceutical Ingredient (API) material. The most significant finding was that the final release specifications for APIs and the company's in-house analytical methods for assay and impurities did not match the specifications submitted in the New Drug Application. Additionally, Patheon had not demonstrated the suitability of its testing method for "Related Substances" in APIs, deviating from regulatory expectations.

Consequently, a "Withhold" recommendation was issued for the pre-approval, indicating that the new drug application will not be approved until Patheon resolves these discrepancies and demonstrates full compliance with its application and relevant regulatory standards. Management was reminded of their responsibility to adhere to regulations to avoid potential enforcement actions.