US FDA Investigators Focusing Inspections On Aseptic Processing Operations
US FDA investigators' increased focus on aseptic operations is resulting in more Form 483 observations of microbiological contamination issues over the past few years.
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Celltrion has received a warning letter from the US Food and Drug Administration (FDA) following an inspection of its manufacturing facility in Incheon, South Korea, carried out in May and June 2017. “The letter raises issues related to certain manufacturing processes at the facility,” Celltrion said. “We are making progress addressing these concerns, and we are committed to working with the agency to fully resolve all outstanding issues with the highest priority.”
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.