# FDA 483 - Kenneth N. Sokolski, M.D. - March 08, 2013

Source: https://www.keypedia.com/records/483/kenneth-n-sokolski-md/d5cad906-09c4-40b5-888c-ccbfe0eb7eac

> FDA 483 for Kenneth N. Sokolski, M.D. on March 08, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenneth N. Sokolski, M.D.
- Inspection Date: 2013-03-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Kenneth N. Sokolski, M.D. (Clinical Innovations, Inc.) in Costa Mesa, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to signed investigator statements and investigational plans, leading to numerous protocol deviations across multiple studies. Additionally, the inspection found a failure to maintain accurate case histories, with multiple discrepancies between source documents and electronic case report forms.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandra-b-pitkin/5e123821-0dd9-4a0d-ba57-f781008cda34)

Company: https://www.keypedia.com/companies/kenneth-n-sokolski-md/951dd56a-55d7-4dbb-8f81-95415f2b17c7

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6