FDA Inspection
Instrumentation LaboratoryInstrumentation Laboratory – FDA Inspection, Aug 24, 2011
Record Details
This FDA Inspection record concerns Instrumentation Laboratory, with an inspection on August 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Instrumentation Laboratory
- Inspection Date
- August 24, 2011
- Product Type
- Devices
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ID · b6b5de4f-795e-4a2f-95ee-55da14f8d20f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742203
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Instrumentation Laboratory
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Instrumentation Laboratory
- FDA Inspection 837911 - 2013-07-12
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