483
Prodose, Inc.Prodose, Inc. – FDA 483, Nov 1, 2023
Record Details
An FDA inspection of Spirit Pharmaceuticals, a packager of OTC drug products in Ronkonkoma, NY, revealed significant deficiencies. Observations included inadequate computer system controls with shared passwords, failure to qualify bulk drug product suppliers, and lack of a written stability testing program to support extended expiry dates. These issues indicate a lack of robust quality control and data integrity practices.
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ID · b74ebc6e-4ac8-48e1-8dbf-e89a13b74163
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