FDA Inspection
Integrated Medical Devices IncIntegrated Medical Devices Inc – FDA Inspection, Sep 21, 2009
Record Details
This FDA Inspection record concerns Integrated Medical Devices Inc, with an inspection on September 21, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 21, 2009
- Product Type
- Devices
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ID · efbe0198-1671-4711-a29b-eb7226fc25d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612469
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(b)Production and process changes - failure to follow procedure
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.184(e)ID label, labeling
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