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FDA Inspection
•Magellan Diagnostics, Inc.•February 23, 2012

Magellan Diagnostics, Inc. – FDA Inspection, Feb 23, 2012

Record Details

This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on February 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
Magellan Diagnostics, Inc.
Inspection Date
February 23, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 4ee7acef-a96e-4554-9d32-18faf91a643a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
765692
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

1
  1. 21 CFR 820.22Quality Audit/Reaudit - conducted

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Magellan Diagnostics, Inc.

6
DateClassificationOfficeProject area
August 26, 2025OAINew England District OfficeCompliance: Medical Devices
June 22, 2021VAICenter for Devices and Radiological HealthCompliance: Devices
October 21, 2019VAICenter for Devices and Radiological HealthCompliance: Devices
June 29, 2017OAICenter for Devices and Radiological HealthCompliance: Devices
June 25, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
View all 6 other inspections on the company page
Other documents for Magellan Diagnostics, Inc.
  • FDA Inspection 1280392 - 2025-08-26
  • FDA Inspection 1144696 - 2021-06-22
  • FDA Inspection 1107302 - 2019-10-21
  • FDA Inspection 1016218 - 2017-06-29
  • FDA Inspection 884803 - 2014-06-25

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