FDA UNTITLED_LETTER - LEESAR, INC - April 29, 2025

FDA UNTITLED_LETTER for LEESAR, INC on April 29, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA UNTITLED_LETTER for LEESAR, INC on April 29, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. § 331(k)

21 U.S.C. 353b

21 CFR 211.180(e)

21 CFR 201.115

21 U.S.C. 360eee-1

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

21 CFR 211.22(d)

21 CFR 211(c)(2)

21 U.S.C. § 352(f)(1)

21 U.S.C. § 351(a)(2)(B)

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Record Information

Company

LEESAR, INC

Inspection Date

April 29, 2025

Product Type

Drugs

Office

Office of Compounding Quality and Compliance

People

F. Gail Bormel (F.)

ID: 44b860c3-98cb-44d4-82a5-a3df576d2475

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