FDA WARNING_LETTER - Premier Trends LLC - September 29, 2021

FDA WARNING_LETTER for Premier Trends LLC on September 29, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Premier Trends LLC on September 29, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.68(a)

21 CFR 211.186(a)

21 CFR 211

21 CFR 211.188

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

21 U.S.C. 360(i)(1)

21 CFR 211.165(a)

21 CFR 210

21 CFR 211.22(a)

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

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Record Information

Company

Premier Trends LLC

Inspection Date

September 29, 2021

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Craig W. Swanson (Deputy District Director)

ID: d95f5ac2-ca7d-4cb6-a2ad-f3a2d196e366

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