FDA 483 - Dental Implant Technologies, Inc - August 22, 2025
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.
An FDA inspection of Dental Implant Technologies, Inc. in Scottsdale, AZ, conducted from August 21-22, 2025, revealed a significant lapse in their quality program. The firm failed to document appropriate corrective actions for a critical temperature monitoring device used for HCT/Ps, which was inoperable for an extended period. This indicates a serious deficiency in ensuring the quality and safety of stored human cells, tissues, and cellular and tissue-based products.
- Office
- Denver District Office
- Person
ID · f9d29110-8530-441f-a7ef-0b4ec5305034