FDA EIR - Berkshire Sterile Manufacturing, LLC - October 15, 2021

FDA EIR for Berkshire Sterile Manufacturing, LLC on October 15, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Berkshire Sterile Manufacturing, LLC on October 15, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.160(b)

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

21 CFR 211.94(c)

21 CFR 211.63

21 CFR 211.84(d)(3)

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Record Information

Company

Berkshire Sterile Manufacturing, LLC

Inspection Date

October 15, 2021

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 012a27c7-8b9d-4727-b75a-0e5804cad8d1

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