FDA Inspection
Pioneer Surgical Technology Inc.Pioneer Surgical Technology Inc. – FDA Inspection, Apr 22, 2010
Record Details
This FDA Inspection record concerns Pioneer Surgical Technology Inc., with an inspection on April 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 22, 2010
- Product Type
- Devices
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ID · cecd0907-c6f9-4664-b074-8047bf889768
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 661206
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.45Sponsor provide device information to investigators
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(b)(1)Statement of risks
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(b)(5)Significant new findings
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 812.43(c)(1)No curriculum vitae in investigator agreement
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Other FDA inspections of Pioneer Surgical Technology Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 11, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Pioneer Surgical Technology Inc.
- FDA Inspection 1229608 - 2024-06-14
- FDA Inspection 1208238 - 2023-05-11
- FDA Inspection 1009643 - 2017-03-28
- FDA Inspection 980045 - 2016-06-23
- FDA Inspection 947458 - 2015-09-24
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