483
Linde, Inc. dba Praxair, IncLinde, Inc. dba Praxair, Inc – FDA 483, Jun 18, 2026
Record Details
Linde Inc., a medical gas manufacturer in Niagara Falls, NY, was cited for significant deficiencies in its Annual Product Quality Review (APQR) procedures and execution. The firm failed to review a representative number of batches and did not adequately incorporate unplanned deviations or out-of-specification results into their APQRs. These issues structurally hindered the identification of trends and continuous improvement efforts for medical gas quality standards.
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ID · 71badc7c-2534-4705-8268-c70f5943d7e2
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