FDA 483 - Ion Labs Inc. - April 28, 2023

Ion Labs Inc., a drug manufacturer and repacker in Largo, FL, received a Form 483 with four observations during an FDA inspection. The firm was cited for deficiencies including a lack of equipment qualification and validation for a blister pack machine, inadequate quality control unit oversight of electronic records and data integrity, and insufficient laboratory controls. Additionally, the inspection revealed failures in conducting complete investigations into unexplained production discrepancies.