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FDA Inspection
•Technology Delivery Systems Inc•March 15, 2016

Technology Delivery Systems Inc – FDA Inspection, Mar 15, 2016

Record Details

This FDA Inspection record concerns Technology Delivery Systems Inc, with an inspection on March 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Technology Delivery Systems Inc
Inspection Date
March 15, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 37704250-4ff7-4f5d-9300-e4c40370e207

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
983494
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.184DHR - not or inadequately maintained
  2. 21 CFR 820.30(g)Design validation - user needs and intended uses
  3. 21 CFR 820.75(c)Documentation - review in response to changes or deviations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Technology Delivery Systems Inc

3
DateClassificationOfficeProject area
June 25, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
May 11, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
March 24, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Technology Delivery Systems Inc
  • FDA Inspection 841079 - 2013-06-25
  • FDA Inspection 724548 - 2011-05-11
  • FDA Inspection 570375 - 2009-03-24

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