FDA Inspection
RG Medical USARG Medical USA – FDA Inspection, Oct 27, 2025
Record Details
This FDA Inspection record concerns RG Medical USA, with an inspection on October 27, 2025, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · 7b247972-e301-4f09-86b8-73095d2cf800
Inspection Facts
- Inspection number
- 1289812
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- 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 820.80(e)Documentation
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