FDA WARNING_LETTER - Izeen Pharma Inc - July 03, 2018

FDA WARNING_LETTER for Izeen Pharma Inc on July 03, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Izeen Pharma Inc on July 03, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

FD&C Act 301(d)

21 U.S.C. 321(p)

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

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 CFR 211

21 U.S.C. 353(b)(1)

21 CFR 210

FD&C Act 301(a)

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Record Information

Company

Izeen Pharma Inc

Inspection Date

July 3, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

Diana Amador-Toro (District Director)

ID: 8be570d7-fed6-4034-a5d4-cc3f07e58121

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