FDA WARNING_LETTER - Lux Therapeutics LLC - June 06, 2025

FDA WARNING_LETTER for Lux Therapeutics LLC on June 06, 2025. Product: Biologics. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Lux Therapeutics LLC on June 06, 2025. Product: Biologics. Access full analysis and detailed observations.

Violation Codes

21 CFR 1271

21 CFR 1271.230(a)

21 CFR 1271.55(b)(2)

21 CFR 1271.55(a)(2)

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Record Information

Company

Lux Therapeutics LLC

Inspection Date

June 6, 2025

Product Type

Biologics

Office

Office of Compliance and Biologics Quality

People

Melissa J. Mendoza (Director)

ID: cc6b8ab3-5c6b-4528-9bbe-b657e58d6cc4

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