483
University Of Texas MD Anderson Cancer Center: PETFDA 483 - University Of Texas MD Anderson Cancer Center: PET - February 16, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Inspection Date
- February 16, 2022
- Product Type
- Drugs
Open in Dashboard
ID · cc89919b-da34-4ef5-b23c-832cd00bdec0