# FDA 483 - Ivan Carreras, M.D. - August 23, 2024

Source: https://www.globalkeysolutions.net/records/483/ivan-carreras-md/a0388942-1232-475f-98d5-f517f74f95a7

> FDA 483 for Ivan Carreras, M.D. on August 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ivan Carreras, M.D.
- Inspection Date: 2024-08-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ivan Carreras M.D./Clintex Research Group, Inc. in Miami, FL, identified a significant issue regarding the retention of investigational product samples. The firm failed to retain the required quantities of test article and reference standard samples for a bioequivalence study, specifically for two shipments. This indicates a deficiency in adherence to regulatory requirements for sample retention.

## Related Officers

- [Chantae D. Mitchell](https://www.globalkeysolutions.net/people/chantae-d-mitchell/0da68244-86f3-4119-b965-0b2dceb1c523)

Company: https://www.globalkeysolutions.net/companies/ivan-carreras-md/2ed8fe7e-b273-4ffb-87a9-0681494d94c6

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