FDA Inspection
Instrumentation Lab CoInstrumentation Lab Co – FDA Inspection, Apr 19, 2017
Record Details
This FDA Inspection record concerns Instrumentation Lab Co, with an inspection on April 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7f915370-e669-4b96-b4db-547fbc3d2769
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014733
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(a)Production processes
- 21 CFR 820.40(a)Document review, approval documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Instrumentation Lab Co
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Instrumentation Lab Co
- FDA Inspection 816600 - 2013-02-27
- FDA Inspection 586277 - 2009-05-21
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