FDA Inspection 783220 — Synergy Health Concepts, Inc.
The FDA completed an inspection of Synergy Health Concepts, Inc. on May 15, 2012 in Newport Beach, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Newport Beach, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |