Novo Nordisk’s US semaglutide manufacturing site under the spotlight again as 2022 monitoring issue surfaces

No­vo Nordisk’s US fa­cil­i­ty has had at least four qual­i­ty con­trol is­sues re­lat­ed to mi­crobes in the past two years. Its Clay­ton, NC site man­u­fac­tures the com­pa­ny’s ac­tive phar­ma­ceu­ti­cal in­gre­di­ent semaglu­tide, used in its block­buster di­a­betes and weight loss drugs.

Man­u­fac­tur­ing con­cerns sur­round­ing “ob­jec­tion­able or­gan­isms” first came to light on Sept. 18, when Mar­ket Wire re­port­ed the com­pa­ny re­ceived a Form 483 which de­tailed is­sues on three sep­a­rate oc­ca­sions this year. A fourth in­stance, as re­port­ed by Reuters on Wednes­day, notes a sim­i­lar is­sue in May 2022.

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