# FDA 483 - University Of Texas MD Anderson Cancer Center: PET - February 16, 2022

Source: https://www.globalkeysolutions.net/records/483/university-of-texas-md-anderson-cancer-center-pet/cc89919b-da34-4ef5-b23c-832cd00bdec0

> FDA 483 for University Of Texas MD Anderson Cancer Center: PET on February 16, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: University Of Texas MD Anderson Cancer Center: PET
- Inspection Date: 2022-02-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: The University of Texas MD Anderson Cancer Center, a PET Drug Manufacturer in Houston, TX, received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in laboratory controls, equipment suitability, data integrity, master production records, and quality unit investigations. These issues indicate a lack of adherence to good manufacturing practices for PET drug products.

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.globalkeysolutions.net/companies/university-of-texas-md-anderson-cancer-center-pet/93691769-5f7c-4b31-a16a-31d5576bfc21

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