FDA WARNING_LETTER - Stason Pharmaceuticals, Inc. - October 25, 2019

FDA WARNING_LETTER for Stason Pharmaceuticals, Inc. on October 25, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Stason Pharmaceuticals, Inc. on October 25, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211

21 CFR 211.68(b)

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

Stason Pharmaceuticals, Inc.

Inspection Date

October 25, 2019

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

ID: 785e47c0-b5ba-4ef1-8e59-3453b4f044e1

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