Californian medical aesthetics company Evolus has stated approval of its flagship product , a Botox alternative , could be delayed after the discovery of manufacturing violations occurring at a South Korean contract manufacturing facility . Following an inspection by the pharmaceutical Food and Drug Administration , Daewoong Pharmaceuticals was slapped with a Form 483 for manufacturing violations , including environmental monitoring , elevated risk of contamination and material handling . Daewoong has appealed to the FDA , but Evolus said in a filing the response would 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.