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•Italy

Tecres S.p.A. - Inspection Records

Inspection records and compliance data for Tecres S.p.A. in Sommacampagna. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected June 15, 2017.

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Company Profile

This profile covers Tecres S.p.A. based in Sommacampagna, None, Italy.

FDA Inspection History

FDA inspections
3
OAI
1
VAI
1
NAI
1
Form 483s
0
Warning letters
1

First inspected January 26, 2012. Last inspected June 15, 2017.

Most cited issue areas

  • Design validation - user needs and intended uses1 inspection
  • Design verification - output does not meet input requirement1 inspection
  • Individual Report of Malfunction1 inspection

Most recent inspections

DateClassificationOfficeProject area
June 15, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
February 5, 2015OAICenter for Devices and Radiological HealthCompliance: Devices
January 26, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Documents (5)
FDA Inspection 1014235 - Tecres S.p.A. - 2017-06-15
fda_inspection
WARNING_LETTER - Tecres S.p.A. - 2015-02-05
WARNING_LETTER
FDA Inspection 915947 - Tecres S.p.A. - 2015-02-05
fda_inspection
FDA Inspection 915947 - Tecres S.p.A. - 2015-02-05
fda_inspection
FDA Inspection 770685 - Tecres S.p.A. - 2012-01-26
fda_inspection
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Company Information

Name

Tecres S.p.A.

FEI Number

3002808402

State

None

City

Sommacampagna

ID: 04c2dccd-3c34-4fe6-b1a4-604ccbc45f78

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