483
Buckeye International IncFDA 483 - Buckeye International Inc - June 28, 2019
Record Details
Buckeye International Inc, an OTC Human Drug Manufacturer in Maryland Heights, MO, was cited for multiple deficiencies in laboratory controls, production procedures, quality unit approvals, and complaint handling. Repeat observations included failure to investigate complaints, validate supplier COAs, and maintain sanitary building conditions. These findings indicate significant quality system issues at the facility.
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ID · 799a1e7d-dd63-4c50-9ff7-8e3c13d9a7f6