FDA 483 - Burpee Materials Technology, LLC - August 08, 2023

Burpee Materials Technology, LLC, a contract manufacturer in Eatontown, NJ, was cited for inadequate documentation of corrective and preventive action activities. The inspection revealed failures to document non-conforming events, including out-of-specification cleanroom particulate results and a missed sterilization process assessment, as required by their internal procedures. This indicates a significant issue with their quality system's handling of non-conformities and CAPA inputs.