FDA EIR - Siegfried USA, LLC - September 27, 2023

An FDA inspection of Siegfried USA, LLC in Pennsville, NJ, was conducted from September 18 to September 27, 2023. This was an unannounced surveillance inspection focusing on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) and a Pre-Approval Inspection (PAI) for a specific ANDA application. The regulatory framework included compliance programs for Pre-Approval Inspections, API Process Inspections, Animal Drug Manufacturing Inspections, and Drug Manufacturing Inspections.

The inspection identified one significant observation, documented on a Form FDA 483, related to the laboratory control system. The firm failed to ensure the suitability and verification of test methods due to improper storage of reference standards. Specifically, primary reference standards, resolution solutions, and reagents were stored in a Quality Control laboratory refrigerator outside the manufacturer’s recommended temperature range (2-8 °C) since November 2022. No investigations were initiated to assess the impact of this temperature excursion on the purity and integrity of these standards, which were subsequently used to release multiple drug products, including Phenobarbital Sodium and Buprenorphine. Furthermore, the firm lacked established written procedures for the quality oversight and maintenance of laboratory refrigeration units.

Siegfried USA, LLC's Senior Vice President and General Manager committed to providing a written response to these observations within 15 business days. Despite the observation, an approval recommendation was issued for the PAI portion of the inspection regarding the ANDA application.