FDA WARNING_LETTER - Red Mountain Inc - October 11, 2018

FDA WARNING_LETTER for Red Mountain Inc on October 11, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Red Mountain Inc on October 11, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(a)

21 U.S.C. 353(b)(4)

21 CFR 211

21 U.S.C. 353(b)(1)

21 CFR 210

21 U.S.C. 353(b)

21 U.S.C. 351(a)(2)(B)

21 U.S.C. 353(b)(1)(A)

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

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Record Information

Company

Red Mountain Inc

Inspection Date

October 11, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

Charles D. Brown (Acting Program Division Director )

ID: 5da3b6f2-6f24-4e0e-8a7d-764a6e07c75a

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