FDA WARNING_LETTER - Clinical Resolution Laboratory Inc. - April 27, 2021

FDA WARNING_LETTER for Clinical Resolution Laboratory Inc. on April 27, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Clinical Resolution Laboratory Inc. on April 27, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(d)

21 U.S.C. 355h

21 U.S.C. 331(a)

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

21 U.S.C. 355h(a)(4)

21 CFR 211

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

21 U.S.C. 355

21 CFR 211.165(a)

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Record Information

Company

Clinical Resolution Laboratory Inc.

Inspection Date

April 27, 2021

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

ID: b89fc920-3fc4-4b9b-87ea-c91aae3476d7

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