FDA Inspection
InvisionHeart, Inc.InvisionHeart, Inc. – FDA Inspection, Mar 31, 2016
Record Details
This FDA Inspection record concerns InvisionHeart, Inc., with an inspection on March 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- InvisionHeart, Inc.
- Inspection Date
- March 31, 2016
- Product Type
- Devices
View Company Profile
ID · e9d5a00b-b012-4b12-a519-76eeb1f2be39
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965132
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 806.20(a)Records not kept
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