483
ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLCFDA 483 - ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC - June 18, 2025
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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
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ID · 96b4e2ae-a71c-4ce8-a672-f67148662725