FDA WARNING_LETTER - Polymer Technology Systems, Inc. - February 15, 2019

FDA WARNING_LETTER for Polymer Technology Systems, Inc. on February 15, 2019. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Polymer Technology Systems, Inc. on February 15, 2019. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 862.9

21 CFR 820.198

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

21 CFR 820.100(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 862.9(c)(9)

21 U.S.C. 360(k)

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Record Information

Company

Polymer Technology Systems, Inc.

Inspection Date

February 15, 2019

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 265dda32-3789-4a6e-81f2-1e58aa2956c3

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