# FDA 483 - James L. Pearle, MD - July 10, 2019

Source: https://www.keypedia.com/records/483/james-l-pearle-md/3c1b53f3-f915-4b93-9411-fb78d4c961d6

> FDA 483 for James L. Pearle, MD on July 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James L. Pearle, MD
- Inspection Date: 2019-07-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of California Research Medical Group Inc. in Fullerton, CA, revealed significant deficiencies in their conduct of clinical investigations. The firm failed to adhere to its investigational plan by reporting serious adverse events late and did not maintain adequate and accurate case histories. These findings indicate a lack of proper oversight and documentation practices in their clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)

Company: https://www.keypedia.com/companies/james-l-pearle-md/28164f5a-3fef-4bfa-b374-1d53b0bc5d45

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