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. The FDA is investigating whether the firm violated federal laws that require companies to ensure their products are free from harmful substances.
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.