# FDA 483 - Impact Clinical Trials - February 11, 2010

Source: https://www.keypedia.com/records/483/impact-clinical-trials/3fc658b4-912d-483f-aea5-6ebe447bbdea

> FDA 483 for Impact Clinical Trials on February 11, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Impact Clinical Trials
- Inspection Date: 2010-02-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Impact Clinical Trials in Los Angeles, CA, revealed significant deficiencies in their conduct of clinical trials. The firm failed to ensure proper informed consent, including not providing critical errata to numerous subjects and using unreadable consent forms. Additionally, the inspection found issues with investigator oversight, as sub-investigators were not properly listed on FDA-1572 forms or did not sign required financial disclosure forms.

## Related Officers

- [investigator](https://www.keypedia.com/people/donna-l-tartaglino-besone/4963b5da-5f7a-413d-a38e-6cbc928ca9a5)

Company: https://www.keypedia.com/companies/impact-clinical-trials/3807e28e-29ba-4249-a32a-09967436b89a

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