FDA 483 - Haupt Pharma Wolfratshausen GmbH - November 12, 2011

Haupt Pharma Wolfratshausen GmbH, a sterile drug manufacturer in Germany, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate cleaning and environmental monitoring in aseptic processing areas, deficient personnel monitoring, and failures in qualification of labeling and packaging lines. Additionally, the firm failed to perform required microbiological and particulate testing on stoppers and did not validate supplier Certificates of Analysis for these materials.