483
Buckeye International IncFDA 483 - Buckeye International Inc - June 28, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · 799a1e7d-dd63-4c50-9ff7-8e3c13d9a7f6