# FDA 483 - Michael E. Gottschalk, M.D. - August 05, 2022

Source: https://www.keypedia.com/records/483/michael-e-gottschalk-md/df62ffe9-04fc-4caf-8ef9-fd5c41da372e

> FDA 483 for Michael E. Gottschalk, M.D. on August 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael E. Gottschalk, M.D.
- Inspection Date: 2022-08-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Michael E. Gottschalk, M.D., a clinical investigator in San Diego, revealed significant deviations from the investigational plan. Observations included incorrect subject randomization, incomplete physical examinations, missed study visits, and out-of-window visit conduct. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the reporting of adverse events and concomitant medications in eCRFs.

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Company: https://www.keypedia.com/companies/michael-e-gottschalk-md/3b333bcd-e981-4c8f-8be5-55323f07ad73

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