483
Univar Solutions USA InCFDA 483 - Univar Solutions USA InC - November 01, 2021
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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.
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ID · 93fdc9a3-6db4-4510-8da6-2b591c967ea7