# FDA 483 - Nicholas Ah Mew, M.D. - July 17, 2019

Source: https://www.keypedia.com/records/483/nicholas-ah-mew-md/1bc9e3df-a34e-4ab4-83c6-57e6783bc2f9

> FDA 483 for Nicholas Ah Mew, M.D. on July 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nicholas Ah Mew, M.D.
- Inspection Date: 2019-07-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Nicholas Ah Mew, M.D., a clinical investigator in Washington, DC, revealed significant deficiencies in clinical trial conduct. Observations included an informed consent document that failed to describe reasonably foreseeable risks to subjects. Additionally, the firm failed to prepare and maintain accurate and complete case histories, with missing data, discrepancies, and lack of investigator review documentation.

## Related Officers

- [Consumer Safety Officer/BIMO Investigator](https://www.keypedia.com/people/david-l-chon/227b9c21-14c4-442b-bdc3-ad167567fd92)

Company: https://www.keypedia.com/companies/nicholas-ah-mew-md/702dafac-dfe3-41e0-a10a-e2495133de43

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e