FDA 483 - Zolberg Corporation - December 07, 2023

An FDA inspection of Zolberg Corporation, a drug manufacturer in Bancal, Philippines, revealed significant deficiencies in quality control, equipment maintenance, and cleaning procedures. The firm failed to ensure final review and approval of batch records, maintained equipment with visible residues and damaged parts, and lacked proper documentation for cleaning effectiveness verification. These observations indicate a failure to adhere to good manufacturing practices.