FDA WARNING_LETTER - Genesis BPS, LLC. - February 11, 2013

FDA WARNING_LETTER for Genesis BPS, LLC. on February 11, 2013. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genesis BPS, LLC. on February 11, 2013. 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)(i)

21 CFR 807.81(b)

21 U.S.C. 352(o)

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Record Information

Company

Genesis BPS, LLC.

Inspection Date

February 11, 2013

Product Type

Devices

Office

New Jersey District Office

People

Diana Amador-Toro (District Director)

ID: b2e6a804-c7e5-46e8-8aed-4d522e0851d1

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