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Home » Form 483: Lapses Identified at Catalent Facility Net Regeneron’s Eylea CRL
Form 483: Lapses Identified at Catalent Facility Net Regeneron’s Eylea CRL
The FDA released a Form 483 from a May 4-12 inspection conducted at Catalent’s Bloomington, Ind., facility pointing to continuing woes for the plant and its customers, with observations of a lack of written production and process control procedures, inadequate equipment revalidation and inadequate cleaning.