FDA Inspection
Emage Medical LLCEmage Medical LLC – FDA Inspection, Sep 26, 2024
Record Details
This FDA Inspection record concerns Emage Medical LLC, with an inspection on September 26, 2024, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 2cd57af9-0aee-4550-ad0d-8ded202613db
Inspection Facts
- Inspection number
- 1229203
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.20(b)(3)(i)Management representative implementing the quality system
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of Emage Medical LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 20, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Emage Medical LLC
- FDA Inspection 1201740 - 2023-04-04
- FDA Inspection 787780 - 2012-06-20
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