FDA WARNING_LETTER - First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - June 14, 2019

FDA WARNING_LETTER for First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy on June 14, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy on June 14, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.166(a)

21 CFR 211.42(c)(10)(iv)

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

21 U.S.C. 331(k)

21 CFR 211

21 CFR 211.94(d)

21 CFR 211.167(a)

21 CFR 211.165(a)

21 CFR 211.42(c)(10)(v)

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Record Information

Company

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Inspection Date

June 14, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

Katherine E. Jacobitz (Director of Investigations Branch)

ID: 5c907a13-d09c-40ad-82a8-9fd0b5a1a103

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