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Inspections and Audits

Our customers visit us on a regular basis to audit our facilities and quality systems. Over 100 such audits took place since the company’s foundation – all to the customers’ satisfaction.

We are also proud of our outstanding track record of inspections from European and US authorities: In 20 years company history, we have never received a critical observation!

  • FDA inspected successfully since 2000
  • cGMP qualified by European authorities since 2006
  • PMDA accreditation for the Japanese market
  • annual inspections by health, safety and environmental agency
  • successfully inspected regarding the safe handling of carcinogenic substances
  • ISO 9001 certified for many years
  • 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
  • more than 100 customer audits

For more details, please refer to our inspection histories by the FDA and by regional German health authorities.

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