FDA Inspection
Instrumentation Lab CoInstrumentation Lab Co – FDA Inspection, Feb 27, 2013
Record Details
This FDA Inspection record concerns Instrumentation Lab Co, with an inspection on February 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Instrumentation Lab Co
- Inspection Date
- February 27, 2013
- Product Type
- Devices
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ID · eee664e9-6865-43fc-81b8-b9ec03e4618c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816600
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Instrumentation Lab Co
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2017 | 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 1014733 - 2017-04-19
- FDA Inspection 586277 - 2009-05-21
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