Californian medical aesthetics company Evolus has said approval of its flagship product, a Botox alternative, could be delayed after the discovery of manufacturing violations found at a South Korean contract manufacturing organisation. Following an inspection by the US Food and Drug Administration, Daewoong Pharmaceuticals was slapped with a Form 10 for 483 violations, including environmental monitoring, elevated risk of contamination and material handling. Daewoong has responded to the FDA, but Evolus said in a filing the response may not be satisfactory.
Californian medical aesthetics company Evolus has said approval of its flagship product, a Botox alternative, could be delayed after the discovery of manufacturing violations found at a South Korean contract manufacturing organisation. Following an inspection by the US Food and Drug Administration, Daewoong Pharmaceuticals was slapped with a Form 483 for 10 violations, including environmental monitoring, elevated risk of contamination and material handling. Daewoong has responded to the FDA, but Evolus said in a filing the response may not be satisfactory.