FDA Inspection
ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLCActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC – FDA Inspection, Jun 18, 2025
Record Details
This FDA Inspection record concerns ActivePure Manufacturing LLC, A wholly owned subsidiary of ActivePure Technologies LLC, with an inspection on June 18, 2025, issued by the Baltimore District Office, covering medical devices & rad health.
- Inspection Date
- June 18, 2025
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · f2634f8d-8666-44df-91f1-24ee6b5a2368
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1274478
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(i)Software validation for automated processes
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