FDA Inspection
Cromsource, Inc.Cromsource, Inc. – FDA Inspection, Jul 16, 2015
Record Details
This FDA Inspection record concerns Cromsource, Inc., with an inspection on July 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cromsource, Inc.
- Inspection Date
- July 16, 2015
- Product Type
- Devices
View Company Profile
ID · 37fbb7ec-9a65-482a-a51a-bbddf6be8678
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939365
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
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