FDA Inspection
Emmy Medical, LLCEmmy Medical, LLC – FDA Inspection, Feb 9, 2016
Record Details
This FDA Inspection record concerns Emmy Medical, LLC, with an inspection on February 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Emmy Medical, LLC
- Inspection Date
- February 9, 2016
- Product Type
- Devices
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ID · 4da3cca5-f377-4d4f-91bf-01258fad458d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 960349
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Emmy Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Emmy Medical, LLC
- FDA Inspection 1088141 - 2019-04-18
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