# FDA 483 - OXYGEN DEVELOPMENT, L.L.C. - September 11, 2025

Source: https://www.keypedia.com/records/483/oxygen-development-llc/b36d2d36-735e-40c3-a882-a4a6d8fdb1ce

> FDA 483 for OXYGEN DEVELOPMENT, L.L.C. on September 11, 2025. 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: 2025-09-11
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Oxygen Development, L.L.C., an OTC manufacturer in Palm Springs, FL, was cited for significant deficiencies in its quality system, laboratory controls, and material handling during an FDA inspection. The firm failed to thoroughly investigate deviations and out-of-specification results, lacked adequate written procedures for raw material release, and did not ensure representative sampling of incoming components. These issues indicate a systemic breakdown in quality control practices that could impact product quality and safety.

## Related Documents

- [483 - 2018-01-17](https://www.keypedia.com/records/483/oxygen-development-llc/8a8320a3-2cff-4b58-955c-fef5cb2a96d1)

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9