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See for yourselves

Inspections and audits


Our customers visit us on a regular basis to audit our facilities and quality systems. Over 150 such audits took place since the company’s foundation – all to the customers’ satisfaction.

We are also looking back on a long and outstanding track record of inspections from European and US authorities. ChemCon's quality has repeatedly been confimed by the inspectors: Since and including the very first inspection in 2000 by the FDA, ChemCon has never received a critical observation!

dateorganizationscopeoutcome
22. - 26. Oct. 2018 Food and Drug Administration (FDA)
Routine inspection for API manufacturing and release, quality assurance systems
Acceptable
24. - 27. Mar. 2014 Food and Drug Administration (FDA)
Routine inspection for API manufacturing and release, quality assurance systems
Acceptable
04. - 07. Jul. 2011 Food and Drug Administration (FDA)
Routine inspection for API manufacturing and release, quality assurance systems
Acceptable
17. - 20. Dec. 2007 Food and Drug Administration (FDA)
Pre-approval Inspection API
Acceptable
03. - 04. Jul. 2000 Food and Drug Administration (FDA)
Pre-approval Inspection API
Acceptable
dateorganizationscopeoutcome
07. Aug. 2019 German health authorities
Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG)
Acceptable
29. Jun. 2018 German health authorities
Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbiological release testing
Acceptable
02. - 03. Nov. 2016 German health authorities
Inspection for API manufacturing and release, quality assurance systems
Acceptable
29. Jan. 2015 German health authorities
Inspection for API manufacturing and release, quality assurance systems
Acceptable
12. – 13. Nov. 2013 German health authorities
Inspection for API manufacturing and release, quality assurance systems
Acceptable
30. Jul. 2013 German health authorities
Inspection acc. to German Pharmaceuticals Act (AMG) for the Authorisation for drug product manufacturing for human use
Acceptable
26. – 27. Sep. 2011 German health authorities
Inspection for API manufacturing and release, quality assurance systems
Acceptable
05. Oct. 2010 German health authorities
Inspection for API manufacturing and release, quality assurance systems
Acceptable
29. – 30. Jul. 2008 German health authorities
Inspection for API manufacturing and release testing on APIs and drug products
Acceptable
24. Jan. 2006 German health authorities
Inspection acc. to German Pharma­ceuticals Act (Arzneimittelgesetz, AMG) for release testing on drug products
Acceptable
24. Jan. 2006 German health authorities
Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbiological release testing
Acceptable
01. Jul. 2003 German health authorities
Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbilological release testing
Acceptable
dateorganizationscopeoutcome
15. – 16. Jan 2015 DEKRA
Audit acc. to DIN EN ISO 9001:2008 (second surveillance audit)
Successful surveillance audit
16. – 17. Jan. 2014 DEKRA
Audit acc. to DIN EN ISO 9001:2008 (first surveillance audit)
Successful surveillance audit
16. – 18. Jan. 2013 DEKRA
Audit acc. to DIN EN ISO 9001:2008
ISO 9001:2008 certification
29. – 30. Nov. 2011 DEKRA
Audit acc. to DIN EN ISO 9001:2008 (second surveillance audit)
Successful surveillance audit
08. – 09. Dec. 2010 DEKRA
Audit acc. to DIN EN ISO 9001:2008 (first surveillance audit)
Successful surveillance audit
04. Dec. 2009 DEKRA
Audit acc. to DIN EN ISO 9001:2008
ISO 9001:2008 certification

Frequent inspections and audits confirm ChemCon's reliable quality

More than 150 customer audits
FDA inspected successfully since 2000 (cGMP)
GMP inspected by European authorities since 2006
PMDA accreditation for the Japanese market
Annual inspections by health, safety and environmental agencies
Successfully inspected regarding the safe handling of carcinogenic substances
License according to the Federal Immission Control Act for the manufacturing of pharmaceutical ingredients, intermediates and fine chemicals
Energy audit according to DIN EN 16247-1 by auditor listed at the Federal Office of Economics and Export Control
ISO 9001 certified for many years

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