FDA con­cerns at con­trac­tor Catal­ent site spurred on short­ages of No­vo Nordisk's semaglu­tide — re­port

Just be­fore the start of the new year, No­vo Nordisk re­vealed its sup­ply of obe­si­ty med We­govy was low and that it would not be able to meet de­mand in the US un­til the sec­ond half of 2022.

Thanks to a Form 483 from the FDA, we now know that is­sues at Catal­ent’s flag­ship sy­ringe fill­ing site in Brus­sels, Bel­gium, was the rea­son for the de­lay, Bio­Process In­ter­na­tion­al re­port­ed.

The site is 265,000 square feet and has been hand­ed 12 483s in nine FDA vis­its, a source told Bio­Process, though it is be­lieved that this is the first that has halt­ed pro­duc­tion.

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