483
Delpharm DijonDelpharm Dijon – FDA 483, May 31, 2024
Record Details
An FDA inspection of Delpharm Dijon, a sterile drug manufacturer in Quetigny, France, revealed significant deficiencies in their manufacturing processes. Observations included inadequate master production and control records lacking theoretical yield and percentage calculations, and a failure to establish appropriate time limits for production phases to ensure drug product quality.
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ID · bd526063-dc9f-4688-9ee5-26a0d5bb1f98
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