FDA WARNING_LETTER - LEC Custom Products, Inc - March 06, 2020

FDA WARNING_LETTER for LEC Custom Products, Inc on March 06, 2020. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LEC Custom Products, Inc on March 06, 2020. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 801(a)(3)

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

21 CFR 211.166(a)

21 U.S.C. 331(a)

21 CFR 211

21 CFR 211.67(a)

21 CFR 210

21 CFR 211.22(a)

21 U.S.C. 361(c)

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Record Information

Company

LEC Custom Products, Inc

Inspection Date

March 6, 2020

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 86237ae9-69e2-4e57-9c2b-37c8f8270031

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