FDA WARNING_LETTER - Philosys Co. Ltd - August 30, 2018

FDA WARNING_LETTER for Philosys Co. Ltd on August 30, 2018. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Philosys Co. Ltd on August 30, 2018. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.70(b)

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

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

21 CFR 803.50(a)(1)

21 CFR 803.12(a)

21 U.S.C. 321(h)

21 U.S.C. 360i

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Record Information

Company

Philosys Co. Ltd

Inspection Date

August 30, 2018

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: d6b23bd1-fc51-43f4-b194-eadbc4b473ba

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