FDA WARNING_LETTER - Biostructures, LLC - May 17, 2010

FDA WARNING_LETTER for Biostructures, LLC on May 17, 2010. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Biostructures, LLC on May 17, 2010. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(a)(3)(ii)

21 U.S.C. 352(o)

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Record Information

Company

Biostructures, LLC

Inspection Date

May 17, 2010

Product Type

Devices

Office

Los Angeles District Office

People

ID: df3b0dd3-ff6b-4727-8ded-571a3a4ef2ec

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