FDA WARNING_LETTER - BioLyte Laboratories, LLC - December 18, 2019

FDA WARNING_LETTER for BioLyte Laboratories, LLC on December 18, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for BioLyte Laboratories, LLC on December 18, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 CFR 310.548(b)

21 U.S.C. 321(p)

21 U.S.C. 355h

21 CFR 211.166(a)

21 U.S.C. 343(y)

21 U.S.C. 343(e)(1)

21 U.S.C. 331(a)

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

21 CFR 211

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Record Information

Company

BioLyte Laboratories, LLC

Inspection Date

December 18, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations III

People

ID: 45eb4a5d-f81a-4182-8f5e-d1d033bb1eea

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