FDA WARNING_LETTER - King Bio Inc. - July 20, 2018

FDA WARNING_LETTER for King Bio Inc. on July 20, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for King Bio Inc. on July 20, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

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

21 U.S.C. 331(a)

21 U.S.C. 353(b)(4)

21 CFR 211

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

21 CFR 210

21 CFR 211.22(a)

21 U.S.C. 353(b)

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

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Record Information

Company

King Bio Inc.

Inspection Date

July 20, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations II

People

ID: fa639628-33b4-4f0f-95d0-ab6315f7c5f3

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