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FDA Inspection
•Cirtec Medical Corporation•August 5, 2016

Cirtec Medical Corporation – FDA Inspection, Aug 5, 2016

Record Details

This FDA Inspection record concerns Cirtec Medical Corporation, with an inspection on August 5, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company
Cirtec Medical Corporation
Inspection Date
August 5, 2016
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 75f44d16-a023-4970-9525-1bd633416f4e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
980876
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
  2. 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cirtec Medical Corporation

3
DateClassificationOfficeProject area
October 15, 2024NAICenter for Devices and Radiological HealthCompliance: Devices
September 9, 2020NAICenter for Devices and Radiological HealthCompliance: Devices
October 29, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Cirtec Medical Corporation
  • FDA Inspection 1234757 - 2024-10-15
  • FDA Inspection 1131004 - 2020-09-09
  • FDA Inspection 854632 - 2013-10-29

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