FDA Inspection
Pioneer Surgical Technology Inc.Pioneer Surgical Technology Inc. – FDA Inspection, Jun 14, 2024
Record Details
This FDA Inspection record concerns Pioneer Surgical Technology Inc., with an inspection on June 14, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d81539bd-6fb0-4214-afdc-fe46621eb0d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229608
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Pioneer Surgical Technology Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 11, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pioneer Surgical Technology Inc.
- FDA Inspection 1208238 - 2023-05-11
- FDA Inspection 1009643 - 2017-03-28
- FDA Inspection 980045 - 2016-06-23
- FDA Inspection 947458 - 2015-09-24
- FDA Inspection 888412 - 2014-07-11
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