FDA WARNING_LETTER - Pharmalab Enterprises, Inc. - June 17, 2019

FDA WARNING_LETTER for Pharmalab Enterprises, Inc. on June 17, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Pharmalab Enterprises, Inc. on June 17, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 111.70(e)

21 CFR 101.3(d)

21 CFR 101.36(b)(3)

21 CFR 111

21 U.S.C. 343(s)(2)(A)

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

21 CFR 101.22(i)(2)

21 CFR 211.160(b)

21 U.S.C. 343(f)

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Record Information

Company

Pharmalab Enterprises, Inc.

Inspection Date

June 17, 2019

Product Type

Drugs

Office

Office of Pharmaceutical Quality Operations Division I

People

ID: 4f359ab3-8dde-442b-8216-d32a423372ee

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