FDA Inspection
Extremity Medical, LLCExtremity Medical, LLC – FDA Inspection, Oct 9, 2012
Record Details
This FDA Inspection record concerns Extremity Medical, LLC, with an inspection on October 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Extremity Medical, LLC
- Inspection Date
- October 9, 2012
- Product Type
- Devices
View Company Profile
ID · 4a74ce2f-337f-46ca-a1d6-398872867680
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803969
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.184Lack of or inadequate DHR procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Extremity Medical, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 17, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 24, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Extremity Medical, LLC
- FDA Inspection 1243318 - 2024-05-20
- FDA Inspection 1108440 - 2019-10-17
- FDA Inspection 983658 - 2016-05-24
- FDA Inspection 747120 - 2011-10-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.