# FDA 483 - Marc R. Bloomenstein, O.D. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/marc-r-bloomenstein-od/7e023060-d9fa-4977-baba-b2d1516579df

> FDA 483 for Marc R. Bloomenstein, O.D. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marc R. Bloomenstein, O.D.
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Marc R. Bloomenstein, O.D., a clinical investigator in Scottsdale, AZ, revealed a significant deficiency in the conduct of a clinical study. The investigation was not performed in accordance with the signed statement of investigator and investigational plan, specifically by enrolling subjects who failed to meet the established eligibility criteria. This indicates a serious deviation from protocol requirements.

## Related Officers

- [Korina Serrano](https://www.globalkeysolutions.net/people/korina-serrano/c96035ff-7eb6-4049-ab6f-248c3c959c3b)

Company: https://www.globalkeysolutions.net/companies/marc-r-bloomenstein-od/8f595492-e21d-4532-bea7-4b16d8248f6f

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face
