FDA WARNING_LETTER - Results RNA, LLC - August 09, 2017

FDA WARNING_LETTER for Results RNA, LLC on August 09, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Results RNA, LLC on August 09, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 343(s)(2)(C)

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 CFR 101.36

21 U.S.C. 321(g)(1)(B)

21 U.S.C. 343(s)(2)(B)

21 CFR 101

21 U.S.C. 343(q)(1)(A)

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Record Information

Company

Results RNA, LLC

Inspection Date

August 9, 2017

Product Type

Drugs

Office

Denver District Office

People

Latonya M. Mitchell (District Director)

ID: 893de274-bfa7-43a7-b84a-b4a29806bdf7

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