FDA 483 - AnuMed International LLC - November 07, 2023

AnuMed International LLC, a contract drug manufacturer in Phoenix, AZ, received an FDA Form 483 with six observations during an inspection from November 1-7, 2023. The firm was cited for significant deficiencies in its quality control unit oversight, incomplete batch production records, inadequate stability testing for expiration dates, and insufficient laboratory controls. Additionally, the inspection revealed a lack of process and cleaning validation, and unsanitary conditions within the facility's warehouse, with several observations being repeats from a previous inspection.