FDA Inspection
Pioneer Surgical Technology Inc.Pioneer Surgical Technology Inc. – FDA Inspection, Jun 23, 2016
Record Details
This FDA Inspection record concerns Pioneer Surgical Technology Inc., with an inspection on June 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 23, 2016
- Product Type
- Devices
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ID · ca84bf4c-e87d-4064-ae36-796fbe3db533
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980045
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 |
| 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 1229608 - 2024-06-14
- FDA Inspection 1208238 - 2023-05-11
- FDA Inspection 1009643 - 2017-03-28
- FDA Inspection 947458 - 2015-09-24
- FDA Inspection 888412 - 2014-07-11
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