FDA Inspection
AmniSure International LLCAmniSure International LLC – FDA Inspection, Nov 18, 2010
Record Details
This FDA Inspection record concerns AmniSure International LLC, with an inspection on November 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AmniSure International LLC
- Inspection Date
- November 18, 2010
- Product Type
- Devices
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ID · a9401e3b-c31e-4bc0-8ef6-c34449287e49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 697628
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Production processes
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