FDA 483 - Products By O2, Inc - October 23, 2023

Products By O2, Inc, an OTC and Homeopathic Drug Manufacturer in Boynton Beach, FL, received an FDA Form 483 citing significant deficiencies across its quality, facilities, production, and laboratory systems. Observations included failures in raw material testing, inadequate annual product reviews and mock recalls, unvalidated cleaning and manufacturing processes, unqualified equipment, and insufficient environmental controls for sample retention. These issues indicate a broad lack of adherence to Good Manufacturing Practices, potentially impacting product quality and safety.