# FDA 483 - Naomi Akita, MD - October 11, 2018

Source: https://www.globalkeysolutions.net/records/483/naomi-akita-md/5d6e7139-f7f3-4840-af78-94378318095c

> FDA 483 for Naomi Akita, MD on October 11, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naomi Akita, MD
- Inspection Date: 2018-10-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Naomi C. Akita, MD, Clinical Investigator, in Suwanee, GA, revealed significant non-compliance across two clinical studies. The firm failed to adhere to the investigational plan by enrolling a subject who met exclusion criteria and did not obtain informed consent from subjects prior to conducting study-related procedures. Additionally, the inspection found inadequate and inaccurate case histories, including inconsistencies in lab sample records, unrecorded treatments, and missing source documents.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sereen-g-morgan-murray/1900ad73-5999-471e-8f74-63627bd1aa2a)

Company: https://www.globalkeysolutions.net/companies/naomi-akita-md/075092cd-09d4-4d9b-afee-859e88a8cc12

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7