# FDA 483 - Oxford Performance Materials, Inc. - August 02, 2024

Source: https://www.keypedia.com/records/483/oxford-performance-materials-inc/4a8bbdc9-e9c0-401c-b182-9417c2768cec

> FDA 483 for Oxford Performance Materials, Inc. on August 02, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxford Performance Materials, Inc.
- Inspection Date: 2024-08-02
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Oxford Performance Materials, Inc. in South Windsor, CT, from July 30 to August 2, 2024, identified a significant regulatory compliance issue. The firm failed to submit multiple Medical Device Reports (MDRs) within the required 30-day timeframe. This indicates a lapse in their reporting procedures for device malfunctions that could cause or contribute to a death or serious injury.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/oxford-performance-materials-inc/f5181cc4-0381-4b41-bc35-15c2d55cb0f8

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144