FDA WARNING_LETTER - Gascó Industrial Corporation - October 18, 2022

FDA WARNING_LETTER for Gascó Industrial Corporation on October 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Gascó Industrial Corporation on October 18, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211

21 CFR 211.42(c)

21 CFR 210

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

21 CFR 211.22

21 CFR 211.34

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Record Information

Company

Gascó Industrial Corporation

Inspection Date

October 18, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

Monica R. Maxwell (Program Division Director)

ID: 71774ffb-67cb-4c3f-9540-9c92aab7c94d

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