FDA 483 - Carbogen Amcis AG - December 12, 2022

Carbogen Amcis AG in Bubendorf, Switzerland, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed significant concerns regarding data integrity, specifically the lack of audit trail review for critical manufacturing and cleaning samples. Additionally, the firm failed to ensure the microbiological suitability of water used in API manufacturing and equipment cleaning, with validation deficiencies and positive test results for contaminants.