FDA WARNING_LETTER - trask and roth inc. - September 22, 2020

FDA WARNING_LETTER for trask and roth inc. on September 22, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for trask and roth inc. on September 22, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21 U.S.C. 331(k)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 U.S.C. 352(o)

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Record Information

Company

trask and roth inc.

Inspection Date

September 22, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy T. Stenzel (Director)

ID: b09cd845-7a15-40ff-8cfe-9b0e1b45d943

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