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FDA Inspection
•Vortran Medical Technology 1, Inc•May 29, 2013

Vortran Medical Technology 1, Inc – FDA Inspection, May 29, 2013

Record Details

This FDA Inspection record concerns Vortran Medical Technology 1, Inc, with an inspection on May 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Vortran Medical Technology 1, Inc
Inspection Date
May 29, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · b741d6ed-2fdf-422e-a152-bbcce3c5be1a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
834679
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
  2. 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Vortran Medical Technology 1, Inc

3
DateClassificationOfficeProject area
July 17, 2024Not classifiedSan Francisco District Office
April 11, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
February 26, 2009NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Vortran Medical Technology 1, Inc
  • FDA Inspection 1246791 - 2024-07-17
  • FDA Inspection 1010791 - 2017-04-11
  • FDA Inspection 566225 - 2009-02-26

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