# FDA 483 - Oscor Inc. - February 11, 2025

Source: https://www.keypedia.com/records/483/oscor-inc/942c026e-7809-41c4-9412-aa67aacbc555

> FDA 483 for Oscor Inc. on February 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oscor Inc.
- Inspection Date: 2025-02-11
- Product Type: device
- Office Name: Florida District Office
- Summary: Oscor Inc., a medical device manufacturer in Palm Harbor, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, resulting in the continued release of potentially defective devices. Additionally, complaint handling procedures were found to be inadequate, as the firm did not complete required health risk assessments for confirmed product defects.

## Related Documents

- [483 - 2019-09-20](https://www.keypedia.com/records/483/oscor-inc/69fce441-8939-4a25-bcbf-51cfb31baa96)
- [483 - 2021-09-10](https://www.keypedia.com/records/483/oscor-inc/05737caf-887c-4336-8e96-1d20a1702d9e)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/oscor-inc/a95066bb-6aae-4335-bb5e-92eebcbf2b17

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