FDA Inspection
Immco Diagnostics, Inc.Immco Diagnostics, Inc. – FDA Inspection, Jul 20, 2017
Record Details
This FDA Inspection record concerns Immco Diagnostics, Inc., with an inspection on July 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 141a7514-3e67-4185-b089-30537de715f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018931
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Immco Diagnostics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Immco Diagnostics, Inc.
- FDA Inspection 822060 - 2013-03-13
- FDA Inspection 717119 - 2011-03-22
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