FDA EIR - Haupt Pharma Wuelfing GmbH - March 17, 2017

An FDA inspection of Haupt Pharma Wulfing GmbH in Gronau, Germany, was conducted from March 9 to March 17, 2017. The inspection, guided by Compliance Program 7371.001 for Animal Drug Manufacturing and referencing programs for general and sterile drug manufacturing, assessed the facility's adherence to current Good Manufacturing Practices (21 CFR 210/211) for products distributed in the United States. The current inspection verified the correction of four deficiencies from a 2015 inspection, which included issues with written production procedures, batch record completeness, facility maintenance, and equipment upkeep. While no formal FDA Form 483 was issued during the 2017 inspection, two verbal comments were raised. These concerned the lack of documented explanations for a 2.5-hour gap in HPLC chromatograms for an assay validation batch and the filling of bulk finished product prior to obtaining certain in-process control results. Haupt Pharma Wulfing GmbH's management committed to immediate corrective actions for these verbal observations. The facility is a contract manufacturer of solid dosage forms and sterile injectable products, though at the time of inspection, only tablets were approved and shipped to the US.