Invacare Corporation – FDA Warning Letter Response, Jun 10, 2011

Record Details

This WARNING LETTER RESPONSE record concerns Invacare Corporation, with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Invacare Corporation
Inspection date: June 10, 2011
Product type: Devices
Office: Center for Devices and Radiological Health
People: Ronnie E. Jackson (Retired Former Director of Compliance)
Gerald Blouch
Tina C. Kelm (Deputy Office Director)
Charles J. Chacko
Jeffrey P. Raimondi (Consumer Safety Officer)

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ID · ac53583d-ee22-4030-bf61-d7003498bfc7

Violation Codes6

21 CFR 820.100(a)(1)21 CFR 820.100(a)(3)21 CFR 820.198(e)21 CFR 820.30(g)21 CFR 803.50(a)(2)21 CFR 820.25(b)

Full citation text and observation details available on the Dashboard.

Other documents for Invacare Corporation

WARNING_LETTER_RESPONSE - 2011-06-30June 30, 2011
WARNING_LETTER_RESPONSE - 2011-04-25April 25, 2011
WARNING_LETTER_RESPONSE - 2011-03-18March 18, 2011
WARNING_LETTER_RESPONSE - 2011-01-28January 28, 2011
WARNING_LETTER_RESPONSE - 2011-01-11January 11, 2011

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WARNING LETTER RESPONSE

Invacare CorporationJune 10, 2011

Invacare Corporation – FDA Warning Letter Response, Jun 10, 2011

Record Details

This WARNING LETTER RESPONSE record concerns Invacare Corporation, with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Invacare Corporation
Inspection date: June 10, 2011
Product type: Devices
Office: Center for Devices and Radiological Health
People: Ronnie E. Jackson (Retired Former Director of Compliance)
Gerald Blouch
Tina C. Kelm (Deputy Office Director)
Charles J. Chacko
Jeffrey P. Raimondi (Consumer Safety Officer)

View Company Profile

ID · ac53583d-ee22-4030-bf61-d7003498bfc7

Violation Codes6

21 CFR 820.100(a)(1)21 CFR 820.100(a)(3)21 CFR 820.198(e)21 CFR 820.30(g)21 CFR 803.50(a)(2)21 CFR 820.25(b)

Full citation text and observation details available on the Dashboard.

Other documents for Invacare Corporation

WARNING_LETTER_RESPONSE - 2011-06-30June 30, 2011
WARNING_LETTER_RESPONSE - 2011-04-25April 25, 2011
WARNING_LETTER_RESPONSE - 2011-03-18March 18, 2011
WARNING_LETTER_RESPONSE - 2011-01-28January 28, 2011
WARNING_LETTER_RESPONSE - 2011-01-11January 11, 2011

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Explore Invacare Corporation