# FDA 483 - Nicola P. Klein, M.D. - January 03, 2022

Source: https://www.keypedia.com/records/483/nicola-p-klein-md/5021070c-0c2d-42a8-8c61-a8af64d9c4da

> FDA 483 for Nicola P. Klein, M.D. on January 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nicola P. Klein, M.D.
- Inspection Date: 2022-01-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Nicola P. Klein, M.D., a clinical investigator in Oakland, CA, was cited for significant deficiencies in conducting and supervising clinical investigations. The inspection revealed failures in ensuring proper subject assessments, adverse event reporting, and maintaining complete case histories, including a missing informed consent form. These issues indicate a lack of adherence to investigational plans and regulatory requirements for clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)
- [Linh Tu](https://www.keypedia.com/people/linh-tu/142c94dc-9538-4c52-9a5f-be27fc7c4f4b)

Company: https://www.keypedia.com/companies/nicola-p-klein-md/c35e465d-c095-4192-bea2-53debf5eded3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b