# FDA 483 - McDougle, Christopher J., MD - March 12, 2004

Source: https://www.globalkeysolutions.net/records/483/mcdougle-christopher-j-md/ca491077-13c4-442e-bbbb-65220cb5c121

> FDA 483 for McDougle, Christopher J., MD on March 12, 2004. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: McDougle, Christopher J., MD
- Inspection Date: 2004-03-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Christopher J. McDougle, M.D., a clinical investigator in Indianapolis, IN, was inspected by the FDA from March 9-12, 2004. The inspection revealed a significant failure to maintain accurate case histories due to numerous data entry errors in study databases. These errors affected adverse event documentation and other subject records, indicating issues with data integrity.

## Related Officers

- [Leigh A. Myers](https://www.globalkeysolutions.net/people/leigh-a-myers/275da932-c51e-461f-80b0-fc94eaaa9edb)

Company: https://www.globalkeysolutions.net/companies/mcdougle-christopher-j-md/7434506e-b610-4bf5-b92d-b86099194dbc

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0