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Inspections by Regional German Health Authorities

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Date Organisation Scope Outcome
01. Jul 2003 German health authority Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbilological release testing Approved facility
24. Jan 2006 German health authority Inspection acc. to German Pharma­ceuticals Act (Arzneimittelgesetz, AMG) for release testing on drug products Approved facility
24. Jan 2006 German health authority Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbiological release testing Approved facility
29. - 30. Jul. 2008 German health authority Inspection for API manufacturing and release testing on APIs and drug products Approved facility
05. Oct. 2010 German health authority Inspection for API manufacturing and release, QA systems Approved facility
26. - 27. Sep. 2011 German health authority Inspection for API manufacturing and release, QA systems Approved facility
30. Jul 2013 German health authority Inspection acc. to German Pharmaceuticals Act (AMG) for the Authorisation for drug product manufacturing for human use Approved facility
12. - 13. Nov. 2013 German health authority Inspection for API manufacturing and release, QA systems Approved facility
29. Jan. 2015 German health authority Inspection for API manufacturing and release, QA systems Approved facility
02. - 03. Nov. 2016 German health authority Inspection for API manufacturing and release, QA systems Approved facility
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