FDA Inspection
NeoCoil, LLCNeoCoil, LLC – FDA Inspection, Jun 2, 2011
Record Details
This FDA Inspection record concerns NeoCoil, LLC, with an inspection on June 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NeoCoil, LLC
- Inspection Date
- June 2, 2011
- Product Type
- Devices
View Company Profile
ID · a278f916-b412-485f-871d-feb18e3906a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727298
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of NeoCoil, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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