FDA Inspection
Orthopedic Alliance LLCOrthopedic Alliance LLC – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Orthopedic Alliance LLC, with an inspection on September 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orthopedic Alliance LLC
- Inspection Date
- September 23, 2011
- Product Type
- Devices
View Company Profile
ID · 9235a277-5f85-4db0-b24f-d6d0c9b740d6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 741729
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Orthopedic Alliance LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Orthopedic Alliance LLC
- FDA Inspection 798966 - 2012-09-11
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