FDA inspections, EU inspections and audits
See for yourselves
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!
| date | organization | scope | outcome |
|---|---|---|---|
| 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 |
| date | organization | scope | outcome |
|---|---|---|---|
| 22. - 24. Oct. 2019 | German health authorities | GMP Inspection for API manufacturing and release, quality assurance systems | Acceptable |
| 07. Aug. 2019 | German health authorities | Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbiological release testing | Acceptable |
| 29. Jun. 2018 | German health authorities | GMP inspection for API quality control testing | Acceptable |
| 02. - 03. Nov. 2016 | German health authorities | GMP Inspection for API manufacturing and release, quality assurance systems | Acceptable |
| 29. Jan. 2015 | German health authorities | GMP Inspection for API manufacturing and release, quality assurance systems | Acceptable |
| 12. – 13. Nov. 2013 | German health authorities | GMP 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 | GMP Inspection for API manufacturing and release, quality assurance systems | Acceptable |
| 05. Oct. 2010 | German health authorities | GMP Inspection for API manufacturing and release, quality assurance systems | Acceptable |
| 29. – 30. Jul. 2008 | German health authorities | GMP Inspection for API manufacturing and release testing on APIs and drug products | Acceptable |
| 24. Jan. 2006 | German health authorities | GMP inspection for API quality control testing | Acceptable |
| 24. Jan. 2006 | German health authorities | Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) | Acceptable |
| 01. Jul. 2003 | German health authorities | Inspection acc. to Infection Protection Act (Infektionsschutzgesetz, IfSG) for microbilological release testing | Acceptable |
| date | organization | scope | outcome |
|---|---|---|---|
| 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 |