Accoring to § 13, 15 AMG-novel (German Drug Law), our laboratory holds a manufacturing license since November, 22nd 2009. We offer the service of a qualified person (QP) for the batch release of human and veterinary drugs for marketing
In February 2005 Phytos successfully passed a product-related FDA audit. Since 04/29/2005 we are registered as laboratory for the FDA under number 3004969119. In July 2009, again a FDA inspection took place. The reason for this second inspection was a pre-approval for an international customer. Phytos successfully passed the four day lasting inspection with the result: "no observations of non-compliance with cGMP regulations on a form 483". Evidence for a successful and consistent implementation of our process-oriented quality system that meets even the highest requirements.
Accreditation according to DIN EN ISO/IEC 17025:2005 for specific and non-specific culture method and the sampling of raw and drinking water
