# FDA 483 - Sarah D. Atkinson, M.D. - April 27, 2018

Source: https://www.globalkeysolutions.net/records/483/sarah-d-atkinson-md/8499f73f-7008-4176-a49e-3f3ba5f6c1f4

> FDA 483 for Sarah D. Atkinson, M.D. on April 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sarah D. Atkinson, M.D.
- Inspection Date: 2018-04-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Sarah D. Atkinson, M.D., a clinical investigator in Rochester, NY, revealed significant issues with the conduct of clinical investigations and the maintenance of accurate records. Observations included a failure to follow the investigational plan, specifically regarding the lack of source data to verify subject eligibility, and a failure to maintain accurate case histories due to undocumented data alterations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)

Company: https://www.globalkeysolutions.net/companies/sarah-d-atkinson-md/b30a86b0-85c7-4013-80e1-6f71c515cc3a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961