# FDA 483 - Herman Ayvazyan, M.D. - January 25, 2024

Source: https://www.globalkeysolutions.net/records/483/herman-ayvazyan-md/b95bd98a-ae37-4c47-a2a5-d2624394e5fa

> FDA 483 for Herman Ayvazyan, M.D. on January 25, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Herman Ayvazyan, M.D.
- Inspection Date: 2024-01-25
- Product Type: drugs
- Office Name: New England District Office
- Summary: Herman Ayvazyan, M.D. in East Providence, RI, was inspected by the FDA from January 18-25, 2024, as a clinical investigator. The inspection revealed a significant issue regarding the maintenance of adequate case histories, specifically the permanent de-identification of informed consent forms for a clinical study. This indicates a serious lapse in record-keeping and subject protection protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jose-a-torres/0c491014-1dd0-4024-99b2-203b830b9c2b)

Company: https://www.globalkeysolutions.net/companies/herman-ayvazyan-md/36163f01-8861-440b-93e7-5dfd0f4ab349

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144
