FDA Inspection 1074668 — Erchonia Corporation, LLC
The FDA completed an inspection of Erchonia Corporation, LLC on Dec 14, 2018 in Fountain Inn, SC. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 14, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fountain Inn, SC (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |