FDA Inspection
Piccguard, LLCPiccguard, LLC – FDA Inspection, Feb 27, 2025
Record Details
This FDA Inspection record concerns Piccguard, LLC, with an inspection on February 27, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 262a111b-b19d-4506-adbe-bb90c95ea924
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1262234
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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