Team passes US authority inspection
Bauerfeind products continue to be certified for export to the US
At the beginning of February, Rainer Berthan sent a congratulatory email on the occasion of the successful inspection carried out by the US Food and Drug Administration, FDA for short. The Chief Executive Officer thanked the entire team and expressed his appreciation for the results that were achieved: Bauerfeind is still authorized to import its products to the US market. This is not a matter of course: an inspector checked Bauerfeind for four days in accordance with strict US law. He merely pointed out four observations. Ines Exner, Head of Regulatory Affairs & Certifications explains exactly what that is, what was checked, and what the inspector took a picture of.
Ines, first of all, congratulations on this excellent result!
Thank you – I would like to pass on these congratulations to everyone involved. The core team included 10 colleagues who have been preparing everything since November, and who answered questions in the inspection room for four days as well as cooperating in the background. Plus, various departments were involved from Product Development, Procurement of Raw Materials and IT to Production and Delivery.
What did the inspector check?
The authority representative checked whether the specifications relating to the development and manufacture of our products are being complied with. Over the four days, the inspector checked various processes relating to VenoTrain range products: pure, micro, delight, and business. It was interesting that he wanted the information provided so he wouldn’t have to ask further questions. That’s different during the annual certification audit. We would usually provide more explanations to go with the documentation. Plus, the audit is based on standards, not on the law as was the case with the FDA. The inspector did have some questions and left us with four observations.
What exactly does that mean?
The inspector was happy overall and said “You are very capable”. He noted that our company’s main processes are working. That’s really good for us. But: we weren’t able to retrieve and show him every single document at the push of a button, even though this is a requirement – complete digital documentation down to the smallest detail, always up-to-date, clear, and at hand. Unfortunately, that’s not something we can do in every case. It’s something we have to work on, and we need to update our Quality Management System (QM) overall based on his findings. We’ve already worked on his four observations and submitted the required corrective actions to the FDA on time within 15 days.
Is there a moment you will remember in particular?
Hmm, let me think... Yes, actually something quite human. The inspector took a picture – of our amazing lunch buffet. A shout-out to Mr. Köber of Aramark. He was very impressed by the finger food.