# FDA 483 - ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC - June 18, 2025

Source: https://www.globalkeysolutions.net/records/483/activepure-manufacturing-llc-a-wholly-owned-subsidiary-of-activepure-technologies-llc/96b4e2ae-a71c-4ce8-a672-f67148662725

> FDA 483 for ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC on June 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC
- Inspection Date: 2025-06-18
- Product Type: device
- Office Name: Baltimore District Office
- Summary: 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.

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/activepure-manufacturing-llc-a-wholly-owned-subsidiary-of-activepure-technologies-llc/43270e31-b70e-4814-ab05-51d5c207db75

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa