FDA WARNING_LETTER - Dr. Joel Kaplan Inc. - June 30, 2023

FDA WARNING_LETTER for Dr. Joel Kaplan Inc. on June 30, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Dr. Joel Kaplan Inc. on June 30, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.22

21 U.S.C. 360(j)

21 U.S.C. 360j(g)

21 CFR 876.5020

21 U.S.C. 351(f)(1)(B)

21 CFR 890.3475

21 CFR 884.5970

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

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Record Information

Company

Dr. Joel Kaplan Inc.

Inspection Date

June 30, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: af1192e5-b6e9-447c-be97-dc1ca93596df

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