483
WES Pharma Inc.WES Pharma Inc. – FDA 483, Nov 20, 2025
Record Details
This FDA Form 483 report details significant deficiencies at WES Pharma Inc. in Westminster, MD, a human drug manufacturer. Observations include failures in thoroughly reviewing discrepancies, inadequate quality control unit authority over data integrity, and insufficient laboratory record review. Additionally, issues were noted with equipment maintenance and the scientific justification for cleaning validation specifications.
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ID · 568aab3e-00d7-49ce-8294-63f21f1fcc8e
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