FDA Inspection 735266 - International Isotopes Inc. - July 22, 2011

FDA Inspection 735266 for International Isotopes Inc. on July 22, 2011. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 735266 for International Isotopes Inc. on July 22, 2011. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(a)

21 CFR 211.122(a)

21 CFR 211.122(f)

21 CFR 211.125(a)

21 CFR 211.150

21 CFR 211.160(b)(4)

21 CFR 211.165(a)

21 CFR 211.166(a)

21 CFR 211.186(b)(8)

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Record Information

Company

International Isotopes Inc.

Inspection Date

July 22, 2011

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: fd0af518-c7b8-49ea-bc52-5c4dcd1951f9

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