FDA Inspection
Pioneer Surgical Technology Inc.Pioneer Surgical Technology Inc. – FDA Inspection, Mar 28, 2017
Record Details
This FDA Inspection record concerns Pioneer Surgical Technology Inc., with an inspection on March 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cf87c971-1a45-47cf-b27d-4ae83ef34862
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009643
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 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 |
| 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 1229608 - 2024-06-14
- FDA Inspection 1208238 - 2023-05-11
- FDA Inspection 980045 - 2016-06-23
- FDA Inspection 947458 - 2015-09-24
- FDA Inspection 888412 - 2014-07-11
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