FDA Inspection
Anatomage, Inc.Anatomage, Inc. – FDA Inspection, Jul 7, 2014
Record Details
This FDA Inspection record concerns Anatomage, Inc., with an inspection on July 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anatomage, Inc.
- Inspection Date
- July 7, 2014
- Product Type
- Devices
View Company Profile
ID · 54b6bded-600c-422b-a1ef-d0fee19591ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 881085
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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