FDA 483 - Avoca, LLC - November 04, 2016

Avoca, Inc. in Menomonee Falls, WI, a fermentation biotechnology facility, was cited for significant deficiencies in its manufacturing processes, quality control, and facility maintenance. The inspection revealed failures in process validation, contamination control, raw material handling, equipment cleaning and sterilization, laboratory instrument qualification, and overall quality management, leading to multiple batches failing due to microbial contamination. The firm also lacked proper documentation, change management, and qualified personnel in its quality department.