483
Linde IncFDA 483 - Linde Inc - March 26, 2026
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Record Details
An FDA inspection of Linde Inc, a medical gas manufacturer and distributor in Stockertown, PA, identified a significant quality control deficiency. The firm failed to establish a written testing program or conduct stability studies for its USP grade gases. This lapse resulted in the manufacturing and distribution of numerous product lots without proper stability assessment.
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ID · 120137c1-539e-47a7-a89a-b4a67c3a98b8