FDA Inspection
OnePacs, LLCOnePacs, LLC – FDA Inspection, Dec 2, 2025
Record Details
This FDA Inspection record concerns OnePacs, LLC, with an inspection on December 2, 2025, issued by the Chicago District Office, covering medical devices & rad health.
- Office
- Chicago District Office
View Company Profile
ID · 7834a780-1f67-45e4-ae81-2b9c6aea32d0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1295314
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
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