The US Food and Drug Administration (FDA) reserves the right to inspect companies worldwide that in particular want to import drugs into the USA .
During this process, laboratories that carry out tests for the approval and release of the drugs are also evaluated. The FDA does not rely exclusively on the inspection reports of the German authority. The basis for the inspections are the GMP requirements laid down by US legislation. These specifications may differ from the European specifications.
During this year’s inspection of the microbiological laboratory of the BAV Institut, all GMP-relevant areas were checked and evaluated. The BAV Institut was able to meet all the requirements satisfactorily, so that there were no deviations or comments. Thus, BAV continues to be fully approved for the field of microbiological investigations.
Customers who are active in the US market or wish to expand there can therefore continue to rely fully on the reliable execution according to FDA specifications and thus on the results of BAV.
BAV Institut GmbH
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