WARNING LETTER

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom CompoundingMarch 10, 2022

FDA WARNING_LETTER - North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - March 10, 2022

FDA WARNING_LETTER for North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding on March 10, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding on March 10, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

21 CFR 211

21 U.S.C. 352(f)(1)

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

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

21 U.S.C. 353a

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Record Information

Company

North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Inspection Date

March 10, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

ID: 931b5611-1845-4df3-ae30-8f31c1caeec1

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