FDA 483 - Loba Feinchemie GmbH - November 03, 2025

Loba biotech GmbH, a drug substance manufacturer in Fischamend, Austria, received a Form 483 with seven observations. The inspection revealed significant deficiencies across manufacturing processes, quality systems, facility maintenance, and personnel training. Key issues include inadequate batch records, deficient validations, poor CAPA implementation, and a lack of robust standard operating procedures and quality oversight.