FDA WARNING_LETTER - TAIWAN BIOTECH CO., LTD. - September 11, 2017

FDA WARNING_LETTER for TAIWAN BIOTECH CO., LTD. on September 11, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for TAIWAN BIOTECH CO., LTD. on September 11, 2017. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

21 CFR 211.166(a)

21 CFR 211.42(c)(10)(iv)

21 CFR 211

21 CFR 210

21 U.S.C. 381(a)(3)

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

21 CFR 211.180(e)

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

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Record Information

Company

TAIWAN BIOTECH CO., LTD.

Inspection Date

September 11, 2017

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Francis Godwin (Director)

ID: 22a3b66c-75de-4b25-a47f-e497676d59fc

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