Quality

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Inspections by the US Food and Drug Administration

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Date Organisation Scope Outcome
03. - 04. Jul. 2000 Food and Drug Administration (FDA) Pre-approval inspection for API manufacturing Approved facility
17. - 20. Dec. 2007 Food and Drug Administration (FDA) Pre-approval inspection for API manufacturing Approved facility
04. - 07. Jul. 2011 Food and Drug Administration (FDA) Routine inspection for API manufacturing and release, QA systems Approved facility
24. - 27. Mar. 2014 Food and Drug Administration (FDA) Routine inspection for API manufacturing and release, QA systems Approved facility
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