FDA 483 - Aptar Radolfzell Gmbh - February 25, 2022

Aptar Radolfzell Gmbh, a sterile drug container closure manufacturer in Riegel-Engen, Germany, received a Form 483 for significant quality system deficiencies. The inspection revealed failures in thoroughly investigating discrepancies and out-of-specification results, a lack of written procedures for production and process controls, and inadequate design verification for their Ophthalmic Squeeze Dispenser (OSD) product. These observations indicate a need for improved quality oversight in manufacturing and design processes.