FDA Inspection
Titus Medical LLC/ SterlingTitus Medical LLC/ Sterling – FDA Inspection, Aug 10, 2015
Record Details
This FDA Inspection record concerns Titus Medical LLC/ Sterling, with an inspection on August 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Titus Medical LLC/ Sterling
- Inspection Date
- August 10, 2015
- Product Type
- Devices
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ID · 81f7c4bf-5a01-4af5-b55d-ef89404b88dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938738
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Titus Medical LLC/ Sterling
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2018 | Not classified | Atlanta District Office |
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