483
ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLCActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC – FDA 483, Jun 18, 2025
Record Details
An FDA inspection of ActivePure Manufacturing LLC in Bristol, VA, revealed significant deficiencies across its quality system. The firm failed to adequately validate software, establish design control procedures, and implement proper training, management review, and equipment calibration protocols. These observations indicate a systemic lack of defined and documented quality processes.
- Inspection date
- June 18, 2025
- Product type
- device
- Person
View Company Profile
ID · 96b4e2ae-a71c-4ce8-a672-f67148662725
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.