FDA Inspection
Integrated Medical Systems International, Inc.Integrated Medical Systems International, Inc. – FDA Inspection, Dec 9, 2015
Record Details
This FDA Inspection record concerns Integrated Medical Systems International, Inc., with an inspection on December 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 9, 2015
- Product Type
- Devices
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ID · 0a69961f-04c8-4a82-a955-f6b51f4f9dda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954817
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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