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!

FDA inspections (US Food and Drug Administration)

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

Inspections by German Health Authorities in behalf of EMA

date	organization	scope	outcome
06.- 08. Sep. 2022	German health authorities	GMP Inspection for API manufacturing and release, quality assurance systems. GMP Inspection for QC testing of excipents, APIs and medical Products.	Acceptable
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

DEKRA audits (ISO)

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

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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Quality & Regulatory

10 Reasons for ChemCon