FDA Inspection
Tango3, LLCTango3, LLC – FDA Inspection, Jul 1, 2014
Record Details
This FDA Inspection record concerns Tango3, LLC, with an inspection on July 1, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tango3, LLC
- Inspection Date
- July 1, 2014
- Product Type
- Devices
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ID · 7a9b08fe-5cd6-494f-a285-c41567ee7252
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
Full citation text and observation details available on the Dashboard.
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 23, 2013 | 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 844236 - 2013-07-23
- FDA Inspection 768466 - 2012-02-10
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