FDA Inspection 1181903 - ALK-Abello, Inc. - October 21, 2022

FDA Inspection 1181903 for ALK-Abello, Inc. on October 21, 2022. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1181903 for ALK-Abello, Inc. on October 21, 2022. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.113(b)

21 CFR 211.160(b)

21 CFR 211.192

21 CFR 211.194(a)(8)

21 CFR 211.42(c)(10)(iii)

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

21 CFR 211.63

21 CFR 211.67(b)(5)

21 CFR 211.80(b)

21 CFR 211.84(d)(1)

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Record Information

Company

ALK-Abello, Inc.

Inspection Date

October 21, 2022

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: f9449cbf-9c0e-45df-b654-e114b0c31e5b

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