483
Pharmaceutics International IncFDA 483 - Pharmaceutics International Inc - July 10, 2020
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Record Details
An FDA inspection of Pharmaceutics International Inc. in Hunt Valley, MD, identified deficiencies in their vendor qualification program. The firm accepted component supplier analyses without adequately validating the reliability of those analyses, failing to perform full testing on critical drug product components. This indicates a significant concern regarding the quality control of incoming materials.
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ID · 643a5cd2-3c8d-4a2b-9a43-e72810bbabac