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

An FDA inspection of Products By O2, Inc., an Over-the-Counter and Homeopathic Drug Manufacturer, conducted from October 17-23, 2023, revealed multiple significant deviations from Good Manufacturing Practices. Key observations included a failure to perform specific identification tests on raw materials, such as Glycerin for diethylene glycol impurities, leading to the distribution of potentially affected drug products. The Quality Unit did not establish Annual Product Reviews or conduct required mock recalls.

Operational deficiencies spanned several areas: cleaning procedures for non-dedicated equipment were unvalidated, and manufacturing equipment, including the water system, lacked proper qualification documentation. Production processes for numerous drug products were not validated, and control procedures for changes to master batch records, SOPs, and new systems were inadequate or non-existent. Laboratory controls were insufficient, notably in the microbiological testing of the water system and temperature monitoring for reserve product samples. Additionally, basic facility issues like a lack of hot water in restrooms and unsecured labeling materials were noted.

Products By O2, Inc. is required to promptly address these observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards and the integrity of its distributed drug products.