FDA 483 - Serumwerk Bernburg AG - June 14, 2024

Serumwerk Bernburg AG, an Active Pharmaceutical Ingredient (API) manufacturer in Bernburg (Saale), Germany, received a Form 483 with two observations. The inspection revealed failures in thoroughly investigating out-of-specification API batches and a lack of established written specifications and control mechanisms for laboratory stability chamber excursions. These issues indicate deficiencies in quality control and manufacturing process oversight.