FDA Inspection 666800 — Ideal Implant Incorporated
The FDA completed an inspection of Ideal Implant Incorporated on May 21, 2010 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Dallas, TX (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14518 | 21 CFR 812.35(a)(3)(iv) | No 5 day notification of IDE change |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |