News

FDA inspection successfully completed

From 11th to 12th February 2019, a Pre Approval Inspection (PAI) by the US Food and Drug Administration (FDA) took place as part of a new product approval in our laboratory.

In addition to the product-specific topics of the PAI, the QA system, the premises and equipment, in particular of the new building, were also inspected. For the third time in a row, we are delighted by the very positive result of the inspection ("no action indicated"). The inspector was particularly impressed by the laboratory tour, the presentation of the documents and the high standard of our quality assurance system.  The cGMP-compliance of Labor LS therefore continues to be given.

This positive result confirms us in our understanding of quality, on which we have continuously worked since the last FDA inspection in 2016 in order to guarantee our customers a high level of testing reliability.

Our Management and the Quality Assurance Team will be pleased to answer any questions you may have at any time (E-mail: Annette.Koenemann@Labor-LS.de, Tel. 09708/ 9100-380).