FDA Inspection
Tango3, LLCTango3, LLC – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns Tango3, LLC, with an inspection on February 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tango3, LLC
- Inspection Date
- February 10, 2012
- Product Type
- Devices
View Company Profile
ID · 5be99188-0b5b-44b4-9034-d92c7b33d1ff
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768466
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Tango3, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tango3, LLC
- FDA Inspection 1107255 - 2019-10-02
- FDA Inspection 1017584 - 2017-06-15
- FDA Inspection 885222 - 2014-07-01
- FDA Inspection 844236 - 2013-07-23
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