FDA WARNING_LETTER - Hudson Radiology Center - January 06, 2014

FDA WARNING_LETTER for Hudson Radiology Center on January 06, 2014. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hudson Radiology Center on January 06, 2014. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 900.12(j)

42 U.S.C. 263b(h)

21 CFR 900.12(f)(1)

21 CFR 900.12(e)(6)

21 CFR 900.12(f)(2)

21 CFR 900.12(a)(1)(ii)(C)

21 CFR 900.12(f)(3)

42 U.S.C. 263b(j)

42 U.S.C. 263b(i)

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Record Information

Company

Hudson Radiology Center

Inspection Date

January 6, 2014

Product Type

Devices

Office

New Jersey District Office

People

Diana Amador-Toro (District Director)

ID: f6370c82-9de0-4921-a402-44eb98ea4b47

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