FDA Inspection
RetroPerc, Inc.RetroPerc, Inc. – FDA Inspection, Dec 18, 2024
Record Details
This FDA Inspection record concerns RetroPerc, Inc., with an inspection on December 18, 2024, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · 4d59bc43-eeac-4fb7-8173-5634f7a0525e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1257324
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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