Company
United StatesPioneer Surgical Technology Inc., Marquette, MI – FDA Inspections
Inspection records and compliance data for Pioneer Surgical Technology Inc. in Marquette, Michigan. 11 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 14, 2024.
Company Profile
This profile covers Pioneer Surgical Technology Inc. based in Marquette, Michigan, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 1
- VAI
- 3
- NAI
- 7
- Form 483s
- 1
- Warning letters
- 0
First inspected September 3, 2009. Last inspected June 14, 2024.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Design input - Lack of or inadequate procedures1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 14, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1229608 |
| May 11, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1208238 |
| March 28, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009643 |
| June 23, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 980045 |
| September 24, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 947458 |
| July 11, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 888412 |
| March 28, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 775297 |
| September 1, 2011 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 742805 |
| December 21, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 703107 |
| April 22, 2010 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 661206 |
| September 3, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 610660 |
FDA documents
Form 483s (2)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pioneer Surgical Technology Inc.
FEI Number
1000115331
Address
375 River Park Cir, Marquette, Michigan 49855, United States
Country
United States
ID: fa3fdd80-2306-4ffb-97f0-f0ff337b1b26