Tyco Healthcare Group LP (dba: Covidien) – FDA Inspection, Mar 22, 2010

Record Details

This FDA Inspection record concerns Tyco Healthcare Group LP (dba: Covidien), with an inspection on March 22, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Tyco Healthcare Group LP (dba: Covidien)
Inspection Date: March 22, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · cfbf6801-227e-4f00-8ec5-a4f63f3eb724

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 656111
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.100(a)(2)Investigation procedures

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FDA Inspection

Tyco Healthcare Group LP (dba: Covidien)March 22, 2010