FDA EIR - Unither Manufacturing LLC. - October 15, 2021

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

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Record Summary

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

Violation Codes

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

21 CFR 820.198

21 CFR 211

21 CFR 211.67(a)

21 CFR 820.100

21 CFR 210

21 CFR 211.192

21 CFR 211.80(a)

21 CFR 211.42(c)(10)(vi)

21 CFR 211.22(d)

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Record Information

Company

Unither Manufacturing LLC.

Inspection Date

October 15, 2021

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 35b5e4b7-c6ab-489a-8767-c6b687e9fd68

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