# FDA 483 - Oscor Inc. - September 20, 2019

Source: https://www.keypedia.com/records/483/oscor-inc/69fce441-8939-4a25-bcbf-51cfb31baa96

> FDA 483 for Oscor Inc. on September 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oscor Inc.
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Oscor, Inc. in Palm Harbor, FL, revealed significant deficiencies in process validation and control procedures for medical device manufacturing. The firm failed to adequately validate critical processes like laser welding and adhesive drying, lacking scientific justification. Additionally, the inspection found that established process control procedures were not followed, including failures to report out-of-range energy readings and maintain proper documentation practices.

## Related Documents

- [483 - 2021-09-10](https://www.keypedia.com/records/483/oscor-inc/05737caf-887c-4336-8e96-1d20a1702d9e)
- [483 - 2025-02-11](https://www.keypedia.com/records/483/oscor-inc/942c026e-7809-41c4-9412-aa67aacbc555)

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

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

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