FDA WARNING_LETTER - Broncolin, S.A. de C.V. - July 29, 2020

FDA WARNING_LETTER for Broncolin, S.A. de C.V. on July 29, 2020. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Broncolin, S.A. de C.V. on July 29, 2020. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 352(j)

21 U.S.C. 321(p)

21 U.S.C. 355h

21 U.S.C. 351(d)(2)

21 U.S.C. 321(n)

21 U.S.C. 331(a)

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

21 U.S.C. 352(a)

21 U.S.C. 352(f)(2)

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Record Information

Company

Broncolin, S.A. de C.V.

Inspection Date

July 29, 2020

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: f14dd043-a209-4558-b7b9-e3dbd7a57528

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