# FDA 483 - Marc C. Gittelman, M.D. - August 26, 2021

Source: https://www.globalkeysolutions.net/records/483/marc-c-gittelman-md/9a9412df-8f9d-48b0-a3bc-bed2d1ff7c5c

> FDA 483 for Marc C. Gittelman, M.D. on August 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marc C. Gittelman, M.D.
- Inspection Date: 2021-08-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Marc C. Gittelman, M.D., Clinical Investigator in Aventura, FL, from August 17-26, 2021, revealed a significant issue with data integrity. The firm failed to maintain accurate case histories, specifically lacking documentation for critical laboratory sample processing procedures for blood collection tubes. This indicates a serious lapse in record-keeping for clinical investigations.

## Related Documents

- [EIR - 2021-08-26](https://www.globalkeysolutions.net/records/eir/marc-c-gittelman-md/11298571-d6a0-4131-bba2-27e4ad9b1c24)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)

Company: https://www.globalkeysolutions.net/companies/marc-c-gittelman-md/e52e5cd9-e3a4-4501-a443-03e09f5c17e8

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