FDA WARNING_LETTER - US Specialty Formulations, LLC - April 26, 2022

FDA WARNING_LETTER for US Specialty Formulations, LLC on April 26, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for US Specialty Formulations, LLC on April 26, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211.113(b)

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

21 U.S.C. 353b(b)(5)

21 CFR 211.166(a)

21 CFR 211.42(a)

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

21 CFR 310.305

21 U.S.C. 331(a)

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

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Record Information

Company

US Specialty Formulations, LLC

Inspection Date

April 26, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: fcafebda-9ba7-4abf-9179-20d80fdfc7b6

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