FDA WARNING_LETTER - Stryer Biotech - October 18, 2007

FDA WARNING_LETTER for Stryer Biotech on October 18, 2007. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Stryer Biotech on October 18, 2007. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.198(a)

21 CFR 820

21 CFR 803

FD&C Act 502(o)

21 U.S.C. 352(o)

21 U.S.C. 321(h)

FD&C Act 515(a)

21 U.S.C. 360e(a)

FD&C Act 520(g)

21 U.S.C. 360j(g)

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Record Information

Company

Stryer Biotech

Inspection Date

October 18, 2007

Product Type

Devices

Office

New England District Office

People

ID: d041302d-866c-4315-baea-dd39badcc32e

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