FDA WARNING_LETTER - Optikem International Inc. - January 26, 2024

FDA WARNING_LETTER for Optikem International Inc. on January 26, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Optikem International Inc. on January 26, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(d)

21 CFR 211.113(b)

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

21 CFR 211.42(c)(10)

21 CFR 211.160(b)

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

21 CFR 211

21 CFR 210

21 CFR 211.22(a)

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Record Information

Company

Optikem International Inc.

Inspection Date

January 26, 2024

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

Lance M. De Souza (Director - Compliance Branch)

ID: bb010de3-ad3a-42d5-bfdc-4de96b3193e3

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