FDA WARNING_LETTER - Sure-Biochem Laboratories, LLC - October 07, 2022

FDA WARNING_LETTER for Sure-Biochem Laboratories, LLC on October 07, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sure-Biochem Laboratories, LLC on October 07, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 211.22(a)

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

21 CFR 211.160(a)

21 CFR 211.34

21 CFR 211.194(a)

21 CFR 211.22(d)

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Record Information

Company

Sure-Biochem Laboratories, LLC

Inspection Date

October 7, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Lisa M. Harlan (Program Division Director)

ID: f9a62d0f-0e66-450e-8e2e-1e9a1d455643

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