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

Source: https://www.keypedia.com/records/483/products-by-o2-inc/c1fb2120-bc11-4286-b998-028018daa199

> FDA 483 for Products By O2, Inc on October 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Products By O2, Inc
- Inspection Date: 2023-10-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/steven-a-brettler/2a356468-f9da-4b68-a3a1-472567e58e45)

Company: https://www.keypedia.com/companies/products-by-o2-inc/20f8ca53-bf8e-4dcc-99fc-7f01df807cb1

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6