FDA Inspection
Emage Medical LLCEmage Medical LLC – FDA Inspection, Apr 4, 2023
Record Details
This FDA Inspection record concerns Emage Medical LLC, with an inspection on April 4, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7441504-9e3f-4ccb-8c62-9bddf462c229
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201740
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Emage Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2024 | Not classified | Atlanta District Office | Compliance: Medical Devices |
| June 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Emage Medical LLC
- FDA Inspection 1229203 - 2024-09-26
- FDA Inspection 787780 - 2012-06-20
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