FDA WARNING_LETTER - Rapid Diagnostics, Division Of Mp Biomedicals, Llc - March 02, 2015

FDA WARNING_LETTER for Rapid Diagnostics, Division Of Mp Biomedicals, Llc on March 02, 2015. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Rapid Diagnostics, Division Of Mp Biomedicals, Llc on March 02, 2015. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360(j)

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

21 U.S.C. 360(p)

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

Rapid Diagnostics, Division Of Mp Biomedicals, Llc

Inspection Date

March 2, 2015

Product Type

Devices

Office

San Francisco District Office

People

Kathleen M. Lewis

ID: f6ac3c19-557d-48de-a5ef-dff8513ec7bf

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