FDA 483 - Loba Feinchemie GmbH - November 03, 2025

Loba biotech GmbH, a drug substance manufacturer in Fischamend, Austria, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across manufacturing processes, quality systems, facility maintenance, and personnel training, indicating a lack of adequate control and oversight. Key issues include inadequate batch record documentation, unresolved aberrant conditions, deficient validations, and poor SOPs and deviation management.