WES Pharma Inc.November 20, 2025

FDA 483 - WES Pharma Inc. - November 20, 2025

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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.

Company: WES Pharma Inc.
Inspection Date: November 20, 2025
Product Type: Drugs
Office: Baltimore District Office
Person: Pushpa S. Jayasekara (Investigator)

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ID · 568aab3e-00d7-49ce-8294-63f21f1fcc8e