FDA WARNING_LETTER - Amerigo Labs LLC - November 13, 2017

FDA WARNING_LETTER for Amerigo Labs LLC on November 13, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Amerigo Labs LLC on November 13, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 335(a)

21 CFR 101.9(c)(8)(iv)

21 U.S.C. 343(y)

21 CFR 101.9(c)(8)(v)

21 U.S.C. 331(a)

21 CFR 101.36

21 CFR 101.36(b)(2)(ii)(B)

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

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Record Information

Company

Amerigo Labs LLC

Inspection Date

November 13, 2017

Product Type

Drugs

Office

Kansas City District Office

People

Cheryl A. Bigham (Division Director)

ID: 1006c1e0-cd1a-41f3-a698-b6ab6a25c06e

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