# FDA 483 - OXYGEN DEVELOPMENT, L.L.C. - January 17, 2018

Source: https://www.keypedia.com/records/483/oxygen-development-llc/8a8320a3-2cff-4b58-955c-fef5cb2a96d1

> FDA 483 for OXYGEN DEVELOPMENT, L.L.C. on January 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OXYGEN DEVELOPMENT, L.L.C.
- Inspection Date: 2018-01-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Oxygen Development, LLC, a drug manufacturer in Palm Springs, FL, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The firm failed to investigate out-of-specification results, adhere to stability testing programs, and validate manufacturing processes for OTC drug products. These issues indicate a systemic lack of adherence to current good manufacturing practices, potentially impacting the identity, strength, quality, and purity of drug products.

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## Related Officers

- [Jennifer L. Huntington](https://www.keypedia.com/people/jennifer-l-huntington/c04e1c86-c7ec-4613-b3f7-a1f9ba2b2f2c)

Company: https://www.keypedia.com/companies/oxygen-development-llc/024c27c1-6cfa-4c7b-9daf-9005cbf515b7

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