# FDA 483 - Gulf Fiberoptics, Inc. - March 23, 2023

Source: https://www.keypedia.com/records/483/gulf-fiberoptics-inc/133eb0bc-a3de-4688-bf66-6a414759a634

> FDA 483 for Gulf Fiberoptics, Inc. on March 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gulf Fiberoptics, Inc.
- Inspection Date: 2023-03-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Gulf Fiberoptics, Inc. in Oldsmar, FL, a manufacturer of Class II endoscopic fiber optic cables and headlights, was inspected by the FDA. The inspection revealed two significant issues related to quality system documentation. Specifically, the firm failed to adequately document corrective and preventive action activities and did not properly maintain its device master record.

## 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/gulf-fiberoptics-inc/b6615066-b9af-4514-9ef1-203cc562deda

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