# FDA 483 - Christopher Romero, M.D. - August 09, 2024

Source: https://www.globalkeysolutions.net/records/483/christopher-romero-md/8839f54d-c66f-4ccd-96f0-2fdc81abd72c

> FDA 483 for Christopher Romero, M.D. on August 09, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Christopher Romero, M.D.
- Inspection Date: 2024-08-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Panamerican Clinical Research Llc in Brownsville, TX, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to maintain proper documentation for subject immunizations and inclusion/exclusion criteria, and did not adequately evaluate or report adverse events as defined by the study protocol. These findings indicate serious deficiencies in the conduct of clinical research.

## Related Officers

- [Audrey J. Yarbrough](https://www.globalkeysolutions.net/people/audrey-j-yarbrough/1bab3d1a-3246-451e-96fb-4ce52185e850)

Company: https://www.globalkeysolutions.net/companies/christopher-romero-md/08048426-d161-459f-aba0-8ce414e6a13a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab