FDA WARNING_LETTER - Auto-Chlor System LLC - July 18, 2022

FDA WARNING_LETTER for Auto-Chlor System LLC on July 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Auto-Chlor System LLC on July 18, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 355h

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 CFR 211

21 U.S.C. 355

21 CFR 210

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

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Record Information

Company

Auto-Chlor System LLC

Inspection Date

July 18, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

ID: 5ed8b14c-7dc9-4ef6-be2e-8274310149f7

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