FDA Inspection 661206 — Pioneer Surgical Technology Inc.
The FDA completed an inspection of Pioneer Surgical Technology Inc. on April 22, 2010 in Marquette, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Marquette, MI (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2937 | 21 CFR 812.43(c)(1) | No curriculum vitae in investigator agreement |
| 2946 | 21 CFR 812.45 | Sponsor provide device information to investigators |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7657 | 21 CFR 50.25(b)(5) | Significant new findings |