FDA WARNING_LETTER - Novel Laboratories, Inc. d.b.a Lupin Somerset - November 05, 2020

FDA WARNING_LETTER for Novel Laboratories, Inc. d.b.a Lupin Somerset on November 05, 2020. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Novel Laboratories, Inc. d.b.a Lupin Somerset on November 05, 2020. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 CFR 211

21 CFR 211.67(a)

21 CFR 210

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

21 CFR 211.67(b)

21 CFR 211.22(d)

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Record Information

Company

Novel Laboratories, Inc. d.b.a Lupin Somerset

Inspection Date

November 5, 2020

Product Type

Drugs

Office

Office of Pharmaceutical Quality Operations Division I

People

ID: 8db1077e-e83a-4e3a-8141-a77b0e62df2c

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