483
FUJIFILM Diosynth Biotechnologies Denmark ApSFDA 483 - FUJIFILM Diosynth Biotechnologies Denmark ApS
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Record Details
Biogen (Denmark) Manufacturing ApS, a drug substance manufacturer in Hillerod, Denmark, was cited for inadequate laboratory testing procedures during an FDA inspection. The firm lacked defined time limits for performing tests after in-process sample collection, specifically for endotoxin samples. This included a lack of studies to support storage conditions for these samples.
- Product Type
- Drugs
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ID · c200d7db-84cd-42a6-91b1-21de41d8d2ac