FDA 483 - Sigma-Aldrich Mfg LLC - March 04, 2020

Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, a medical device manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately validate a new filler and packaging line for a Class 3 medical device, lacked proper procedures for controlling nonconforming products, and did not document rework activities in device history records. Additionally, the inspection revealed that requirements for suppliers and contractors were not adequately established, with two suppliers not being on the approved list.