FDA WARNING_LETTER - Oralabs Inc. - September 26, 2025

FDA WARNING_LETTER for Oralabs Inc. on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Oralabs Inc. on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211

21 CFR 210

21 CFR 211.192

21 CFR 211.165(b)

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

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Record Information

Company

Oralabs Inc.

Inspection Date

September 26, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

ID: c66c0fe0-8857-4b2d-8dd2-bf735a0ca632

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