FDA Inspection 1218588 - Berkeley Biologics LLC - September 25, 2023

FDA Inspection 1218588 for Berkeley Biologics LLC on September 25, 2023. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1218588 for Berkeley Biologics LLC on September 25, 2023. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 1271.160(b)(4)

21 CFR 1271.230(a)

21 CFR 1271.47(a)

21 CFR 1271.75(a)(1)

21 CFR 1271.75(d)

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Record Information

Company

Berkeley Biologics LLC

Inspection Date

September 25, 2023

Product Type

Biologics

Office

Center for Biologics Evaluation and Research

ID: 03373494-ad76-49bb-9f0e-95d3f4939f30

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