FDA WARNING_LETTER - Laboratorio Pharma International SRL - September 21, 2021

FDA WARNING_LETTER for Laboratorio Pharma International SRL on September 21, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Laboratorio Pharma International SRL on September 21, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

FD&C Act 801(a)(3)

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

21 CFR 211.166(a)

21 CFR 211.160(b)

21 U.S.C. 331(a)

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

21 CFR 211

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

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Record Information

Company

Laboratorio Pharma International SRL

Inspection Date

September 21, 2021

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 52df36ac-3969-42b8-ad4b-272e0ce17c50

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