FDA Inspection
Insource Orthopedics, LLCInsource Orthopedics, LLC – FDA Inspection, Aug 25, 2009
Record Details
This FDA Inspection record concerns Insource Orthopedics, LLC, with an inspection on August 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Insource Orthopedics, LLC
- Inspection Date
- August 25, 2009
- Product Type
- Devices
View Company Profile
ID · c9ef7e69-436f-4a5f-b2eb-6efa13980305
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607359
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(b)Establish the design and development plan
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.25(b)Training
- 21 CFR 820.25(a)Sufficient personnel
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.160(a)Control/distribution procedures
- 21 CFR 820.100(a)(3)Identifying corrective & preventive actions
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Other FDA inspections of Insource Orthopedics, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 26, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Insource Orthopedics, LLC
- FDA Inspection 1153740 - 2021-08-25
- FDA Inspection 1069140 - 2018-08-27
- FDA Inspection 773850 - 2012-03-26
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