FDA Inspection
Immunostics, Inc.Immunostics, Inc. – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns Immunostics, Inc., with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ec9c9d51-f903-4419-93e0-ecd94c1dfe8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031471
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Immunostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 18, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 13, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Immunostics, Inc.
- FDA Inspection 808912 - 2012-12-03
- FDA Inspection 709502 - 2011-02-18
- FDA Inspection 671330 - 2010-07-13
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