FDA WARNING_LETTER - Augustine Temperature Management, LLC - September 19, 2023

FDA WARNING_LETTER for Augustine Temperature Management, LLC on September 19, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Augustine Temperature Management, LLC on September 19, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 803.17(a)(1)

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

21 CFR 803.18(b)(1)(i)

21 CFR 803.17(a)(3)

21 CFR 803.3

21 CFR 803.50(a)(1)

21 CFR 803.12(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.80(b)

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Record Information

Company

Augustine Temperature Management, LLC

Inspection Date

September 19, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 71655304-4222-4f52-8c8e-4233ee124497

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