FDA WARNING_LETTER - Epicare Acquisitions, Llc - December 13, 2024

FDA WARNING_LETTER for Epicare Acquisitions, Llc on December 13, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Epicare Acquisitions, Llc on December 13, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801

21 CFR 801.40(a)(2)

21 U.S.C. 331(q)(1)(B)

21 U.S.C. 352(t)(2)

21 CFR 820.198

21 CFR 820.198(d)

21 CFR 830.320(b)

21 CFR 820.25(b)

21 U.S.C. 360oo(a)(1)

21 CFR 820.100(a)

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Record Information

Company

Epicare Acquisitions, Llc

Inspection Date

December 13, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: e9147315-88b3-4ce0-988f-1a05aab3e07f

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