FDA Inspection
Deymed Diagnostic SRODeymed Diagnostic SRO – FDA Inspection, Jul 27, 2023
Record Details
This FDA Inspection record concerns Deymed Diagnostic SRO, with an inspection on July 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d409bf38-ced7-4c10-9d2f-64663ed64389
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1214862
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Deymed Diagnostic SRO
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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