FDA Inspection
Immunetech, Inc.Immunetech, Inc. – FDA Inspection, Mar 23, 2012
Record Details
This FDA Inspection record concerns Immunetech, Inc., with an inspection on March 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Immunetech, Inc.
- Inspection Date
- March 23, 2012
- Product Type
- Devices
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ID · 5763d9fc-6d64-45b6-9d67-9644465b831a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Immunetech, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 1, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Immunetech, Inc.
- FDA Inspection 835839 - 2013-06-13
- FDA Inspection 696173 - 2010-11-01
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