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

Ion Labs Inc., located in Largo, FL, underwent an unannounced, comprehensive FDA inspection from April 24 to April 28, 2023. The inspection focused on their operations as a contract manufacturer and packager for Over-the-Counter (OTC) drugs, dietary supplements, and cosmetics, specifically evaluating adherence to current Good Manufacturing Practices (cGMP) for drug manufacturing. The FDA issued a Form FDA 483 detailing significant deficiencies. Key violations included the firm's failure to qualify equipment (specifically a blister pack machine), validate processes, and validate cleaning procedures for packaging operations. The quality control unit demonstrated a lack of oversight, evidenced by uncontrolled analytical forms, unreliable scanned cleaning logs, absence of equipment use logbooks for laboratory instruments, and a failure to review electronic data from the FTIR instrument, which also lacked an enabled audit trail. Additionally, annual product reviews were not conducted for certain products, and laboratory controls were inadequate, with no growth promotion testing for in-house prepared media and incomplete deviation investigations. Management, led by Vice President of Quality and Regulatory Affairs Mr. Dennis G. Herd, acknowledged the observations, committed to implementing corrective actions, and promised a written response within fifteen business days, alongside updating drug registration and listing information.