483
Llorens Pharmaceuticals International Division, Inc.Llorens Pharmaceuticals International Division, Inc. – FDA 483, May 15, 2025
Record Details
An FDA inspection of Llorens Pharmaceuticals International Division, Inc. in Miami, FL, an OTC drug and dietary supplement manufacturer, revealed two significant observations. The firm's stability program for drug products lacked reliable test methods, specifically failing to perform force degradation studies on OTC products. Additionally, the Quality Unit did not fully follow established procedures for sampling and testing purified water, including documentation of water discarding times.
- Inspection date
- May 15, 2025
- Product type
- drugs
- Office
- Florida District Office
- Person
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ID · 4daca291-097a-41f3-b7cc-d68bc7da5ee1
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