FDA 483 - Siegfried USA, LLC - September 27, 2023

Siegfried USA, LLC in Pennsville, NJ, an API manufacturer, received a Form 483 following an inspection from September 18-27, 2023. The inspection revealed that primary reference standards, resolution solutions, and reagents were stored outside of recommended temperature conditions since November 2022 without proper investigation. Additionally, the firm lacked written procedures for the quality oversight of laboratory refrigeration units, impacting the suitability and verification of test methods.