FDA 483 - Herbrand PharmaChemicals GmbH

An FDA inspection of Herbrand PharmaChemicals GmbH, an API manufacturer in Gengenbach, Germany, revealed significant deficiencies in laboratory controls, data integrity, and record-keeping practices. Observations included a lack of audit trails on critical lab instruments, unauthorized access to testing functions, and inadequate control over batch production records and deviation tracking. These issues indicate a lack of assurance in the quality and purity of their raw materials, in-process materials, and APIs.