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FDA Inspection
•Quartet Technology, Inc.•February 4, 2011

Quartet Technology, Inc. – FDA Inspection, Feb 4, 2011

Record Details

This FDA Inspection record concerns Quartet Technology, Inc., with an inspection on February 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Quartet Technology, Inc.
Inspection Date
February 4, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 69ed4d5b-d501-4e1a-9bc5-655b0f2c75bd

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
710542
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

4
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  3. 21 CFR 820.22Quality Audit/Reaudit - conducted
  4. 21 CFR 820.20(e)Quality System Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Quartet Technology, Inc.

2
DateClassificationOfficeProject area
May 29, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
February 1, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Quartet Technology, Inc.
  • FDA Inspection 880727 - 2014-05-29
  • FDA Inspection 765859 - 2012-02-01

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