FDA WARNING_LETTER - Tris Pharma Inc. - March 20, 2017

FDA WARNING_LETTER for Tris Pharma Inc. on March 20, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Tris Pharma Inc. on March 20, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

FD&C Act 501(a)(2)(B)

21 CFR 211

21 CFR 210

21 CFR 211.192

21 U.S.C. 351(a)(2)(B)

21 CFR 211.34

21 U.S.C. 356C(b)

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Record Information

Company

Tris Pharma Inc.

Inspection Date

March 20, 2017

Product Type

Drugs

Office

New Jersey District Office

People

ID: c35be989-8a74-4f88-9f30-bc0eaa051dad

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