# FDA 483 - Dr. Bruce G. Rankin, DO - September 22, 2023

Source: https://www.keypedia.com/records/483/dr-bruce-g-rankin-do/08cf5ded-135d-4c36-a218-5ccc4f3bfd61

> FDA 483 for Dr. Bruce G. Rankin, DO on September 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Bruce G. Rankin, DO
- Inspection Date: 2023-09-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Dr. Bruce G. Rankin, DO, a bioequivalent clinical facility in Deland, FL, revealed a significant issue regarding the conduct of an investigation. The firm failed to retain reserve samples for test or reference products as required by the investigational plan and protocol. This indicates a lapse in adherence to study protocols and good clinical practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/emily-a-baldwin/92d70174-7029-44f4-af30-e3230d4e9507)

Company: https://www.keypedia.com/companies/dr-bruce-g-rankin-do/e17db3fc-0266-4df0-9179-eb664fb264cb

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