FDA WARNING_LETTER - GlaxoSmithKline - November 13, 2007

FDA WARNING_LETTER for GlaxoSmithKline on November 13, 2007. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for GlaxoSmithKline on November 13, 2007. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 314.80(c)(2)(ii)(c)

21 CFR 314.81(b)(2)(vii)

21 CFR 314.80

21 CFR 314.81(b)(2)(viii)

21 U.S.C. 331(e)

21 U.S.C. 355(k)(1)

21 CFR 314.81

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Record Information

Company

GlaxoSmithKline

Inspection Date

November 13, 2007

Product Type

Drugs

Office

Atlanta District Office

People

ID: f477aa59-1232-4ce5-838b-6daaf9cf8b6d

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