# FDA 483 - Claudia R. Padilla, M.D. - November 12, 2021

Source: https://www.globalkeysolutions.net/records/483/claudia-r-padilla-md/1957be82-1b92-4480-bee6-a4fdf43c102b

> FDA 483 for Claudia R. Padilla, M.D. on November 12, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Claudia R. Padilla, M.D.
- Inspection Date: 2021-11-12
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Claudia R. Padilla, M.D. in Dallas, TX, revealed significant deviations from the investigational plan during a clinical study. The firm failed to document the review of electrocardiograms for multiple subjects as required by the protocol. Additionally, laboratory specimens were improperly stored on-site and shipped late, rendering them beyond stability for analysis.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)

Company: https://www.globalkeysolutions.net/companies/claudia-r-padilla-md/76c5567f-ed97-476a-9a4d-a090a5b049c9

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