FDA 483 - Fareva Unterach GmbH - May 08, 2019

An FDA inspection of Ebewe Pharma Ges.m.b.H.Nfg. KG in Unterach am Attersee, Austria, from April 29 to May 8, 2019, revealed significant deficiencies in their manufacturing processes. The firm failed to establish scientifically sound sampling plans for laboratory controls to ensure component quality and purity. Additionally, the written stability testing program was not followed, and electronic records were found to be incomplete and unreliable.