FDA Inspection
Pensar Medical LLCPensar Medical LLC – FDA Inspection, Sep 12, 2012
Record Details
This FDA Inspection record concerns Pensar Medical LLC, with an inspection on September 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pensar Medical LLC
- Inspection Date
- September 12, 2012
- Product Type
- Devices
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ID · f9bf3d75-85e8-4a4f-8043-7e4f3636280e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799153
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Pensar Medical LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2026 | Not classified | Dallas District Office | Compliance: Devices |
| February 16, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pensar Medical LLC
- FDA Inspection 1314396 - 2026-04-28
- FDA Inspection 1197633 - 2023-02-16
- FDA Inspection 975316 - 2016-03-11
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