FDA Inspection
Synergy Health Concepts, Inc.Synergy Health Concepts, Inc. – FDA Inspection, May 15, 2012
Record Details
This FDA Inspection record concerns Synergy Health Concepts, Inc., with an inspection on May 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 15, 2012
- Product Type
- Devices
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ID · 2f2a775b-1188-4d04-bb3c-c4149e5f008e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 783220
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(d)Record retention inadequate
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