FDA Inspection 845693 - Aptalis Pharma Us Inc - August 29, 2013

FDA Inspection 845693 for Aptalis Pharma Us Inc on August 29, 2013. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 845693 for Aptalis Pharma Us Inc on August 29, 2013. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 803.17(b)(1)

21 CFR 806.20(b)(4)

21 CFR 820.100(a)

21 CFR 820.100(b)

21 CFR 820.181

21 CFR 820.198(a)

21 CFR 820.20(c)

21 CFR 820.22

21 CFR 820.30(i)

21 CFR 820.80(a)

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Record Information

Company

Aptalis Pharma Us Inc

Inspection Date

August 29, 2013

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f7272c58-404a-440a-98e7-5e04c84fe7d7

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