FDA WARNING_LETTER - Bayer HealthCare LLC - Unknown Date

FDA WARNING_LETTER for Bayer HealthCare LLC on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Bayer HealthCare LLC on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 321(p)

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

21 U.S.C. 352(a)

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

21 U.S.C. 321(g)(1)(B)

21 U.S.C. 321(g)

21 U.S.C. 352(f)(1)

21 U.S.C. 321(g)(1)(C)

21 CFR 210.3(b)(3)

21 CFR 343.80

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Record Information

Company

Bayer HealthCare LLC

Inspection Date

Unknown Date

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Deborah M. Autor (Former FDA Deputy Commissioner)

ID: ea71d96f-9b56-4221-98cf-16754474b28e

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