FDA Inspection
I-Sens, Inc.I-Sens, Inc. – FDA Inspection, Feb 12, 2014
Record Details
This FDA Inspection record concerns I-Sens, Inc., with an inspection on February 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- I-Sens, Inc.
- Inspection Date
- February 12, 2014
- Product Type
- Devices
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ID · bd31ddd3-acd0-49d5-b036-c3e190488e65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868284
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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