FDA 483 - Hawaii Pharm LLC - November 07, 2019

An FDA inspection of Hawaii Pharm LLC in Honolulu, HI, a dietary supplement manufacturer, revealed significant deficiencies in their manufacturing processes. The firm failed to establish identity and product specifications, prepare master manufacturing and batch production records, and maintain proper complaint handling procedures. Additionally, issues were noted with reserve sample collection and supplier qualification documentation, indicating a broad lack of adherence to good manufacturing practices.