FDA 483 - Univar Solutions USA InC - November 01, 2021

Univar USA Inc. in Kent, WA, a repacker/packer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in batch production and control records, including incomplete documentation and missing signatures/dates. Additionally, the firm failed to consistently follow its written production and process control procedures, specifically regarding yield calculation documentation for repacking operations.