FDA Inspection 791292 — Ideal Implant Incorporated
The FDA completed an inspection of Ideal Implant Incorporated on Jul 20, 2012 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Dallas, TX (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 3002 | 21 CFR 812.140(b)(5) | Sponsor records of adverse device effects & complaints |