FDA Inspection
Extremity Medical, LLCExtremity Medical, LLC – FDA Inspection, Oct 24, 2011
Record Details
This FDA Inspection record concerns Extremity Medical, LLC, with an inspection on October 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Extremity Medical, LLC
- Inspection Date
- October 24, 2011
- Product Type
- Devices
View Company Profile
ID · b82483d8-0124-49c1-b458-0f7d2f02a8b2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 747120
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
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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 9, 2012 | VAI | 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 803969 - 2012-10-09
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