FDA Inspection
Tango3, LLCTango3, LLC – FDA Inspection, Jul 23, 2013
Record Details
This FDA Inspection record concerns Tango3, LLC, with an inspection on July 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tango3, LLC
- Inspection Date
- July 23, 2013
- Product Type
- Devices
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ID · d9709827-7c37-4ed0-8332-2027471dedfb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844236
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - production units
Showing 10 of 11 citations.
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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 |
| February 10, 2012 | OAI | 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 768466 - 2012-02-10
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