483
Catalent Greenville IncCatalent Greenville Inc – FDA 483, Oct 24, 2025
Record Details
The FDA inspected Catalent Greenville Inc, a contract drug manufacturer, and issued a Form 483 with three observations. The inspection revealed significant issues across equipment maintenance, microbial testing, and stability program adherence, indicating potential risks to drug product quality and safety. Specifically, observations included unvalidated equipment modifications, worn equipment, inadequate microbial testing and identification, and poor control over stability samples.
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ID · 4533beac-cc6a-41f8-8d08-00ecde98205c
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