FDA EIR - Siegfried (Nantong) Pharmaceuticals Co., Ltd. - August 16, 2019

An FDA Pre-Approval Inspection of Siegfried (Nantong) Pharmaceuticals Co., Ltd. in Nantong, China, was conducted from August 12-16, 2019. This marked the facility's first FDA inspection, requested by the Center for Veterinary Medicine (CVM) to evaluate readiness for manufacturing an Active Pharmaceutical Ingredient (API) for a New Animal Drug Application. The inspection adhered to CPGM 7369.001, focusing on commercial manufacturing readiness, conformance to the application, data integrity, and commitment to quality in pharmaceutical development.

The primary issue identified was a recurring trend of Out-of-Specification (OOS) results for a critical raw starting material used in API production. Investigations, including ten in-depth reviews, suggested a problem with the analytical instrument or method for purity and impurity analysis. Management acknowledged initial method transfer results were acceptable, yet the same analytical equipment was later suspected of causing multiple OOS findings. The investigation was still open, with no definitive conclusion on vendor requalification or re-validation of the analytical method. Affected raw material batches were quarantined.

Despite these observations, no FDA Form 483 (Inspectional Observations) was issued at the closeout meeting. The firm received an "Acceptable" recommendation for its role as a manufacturer/supplier of the API, which was to be forwarded to the Foreign Pre-approval Manager. This outcome indicates that while issues were discussed, no formal regulatory actions were immediately mandated by the FDA.