Successful FDA inspection in September 2015

Since the beginning of API production activities, the site has a long and successful track record of health authorities’ inspections.

Minakem High Potent is very pleased to announce that our Louvain-La Neuve site has been successfully audited by the FDA.

The purpose of the audit was a general site audit focused on several products including exclusive manufactures as well as anti-cancer Vinca alkaloids HP API such as Vinorelbine, Vinblastine & Vincristine. The standards of the site have been considered by FDA as directly acceptable with No Action Indicated (NAI) and no 483.

This outstanding result obtained less than 3 months after the acquisition and still in a transition period of time shows the quality of Minakem High potent QA system together with the professionalism of the successful exiting teams and structures.

We shall now focus on working closely with your QA team in order to maintain and develop our Quality standards.

We, at Minakem High Potent, are dedicated to keep serving you at best and willing to develop our activities with your new products & projects using our highest standards both in terms of Quality and Safety.

US FDA INSPECTIONS

  • September 2015 (Routine)

EUROPEAN INSPECTIONS

  • September 2015