483
Catalent Belgium SACatalent Belgium SA – FDA 483, Jun 19, 2019
Record Details
An FDA inspection of Catalent Belgium SA, a manufacturer of sterile drug products in Brussels, revealed significant deficiencies. Observations included inadequate procedures to prevent microbiological contamination, insufficient control procedures for manufacturing processes, and incomplete laboratory records. These issues indicate potential risks to product quality and integrity.
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ID · 0bdc03da-0772-4c63-92a1-bf5a5e92ae50
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