FDA Inspection
Telcare, LLCTelcare, LLC – FDA Inspection, Mar 1, 2016
Record Details
This FDA Inspection record concerns Telcare, LLC, with an inspection on March 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Telcare, LLC
- Inspection Date
- March 1, 2016
- Product Type
- Devices
View Company Profile
ID · 37161b6c-8d33-46c5-a955-2d013f7c1a24
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964997
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 803.50(a)(2)Individual Report of Malfunction
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Telcare, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Telcare, LLC
- FDA Inspection 1079841 - 2019-02-06
- FDA Inspection 846110 - 2013-08-27
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