FDA WARNING_LETTER - Baxa Corporation - July 30, 2007

FDA WARNING_LETTER for Baxa Corporation on July 30, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Baxa Corporation on July 30, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

21 CFR 820.30(i)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.20(c)

21 CFR 820.198(c)

21 CFR 803.50(b)(3)

21 CFR 803.50(a)(2)

21 U.S.C. 351(h)

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Record Information

Company

Baxa Corporation

Inspection Date

July 30, 2007

Product Type

Devices

Office

Denver District Office

People

Susan M. Miller (Research and Evaluation Consultant)

ID: 0bf53a5a-c0f7-4661-845b-4436f41c192c

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