Warning letter
Pioneer Surgical Technology [ARCHIVED]: warning letter of Aug 3, 2010
FDA warning letter 114668 · Center for Devices and Radiological Health
Key facts
| Reference number | 114668 |
|---|---|
| Company | Pioneer Surgical Technology [ARCHIVED] |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Aug 3, 2010 |
| Posted date | Aug 3, 2010 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 812.43(c)(5), 812.7(d), 812.140(b)(2), 54, 50, 50.25(a), 812.7, 812.40, 812.45 |
| Inspection city | Marquette |
| Inspection ZIP | 49855 |
| Inspection start date | Apr 19, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: