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The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.
LSNE Contract Manufacturing, a contract development and manufacturing organization headquartered in Bedford, NH, announced on Jan. 21, 2020 that FDA completed a successful pre-approval inspection at its aseptic fill/finish facility in León, Spain.
According to a company press release, the inspection, which took place in January 2020, was found to be compliant with no Form 483 observations issued. The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.
“This inspection was a critical milestone for LSNE and its newest site within LSNE’s global network,” said Tom McGrath, vice-president of Quality and Regulatory, LSNE, in the press release. “This marks the second successful FDA inspection at LSNE-León and demonstrates the site’s alignment and commitment to LSNE’s core values of quality and compliance.”
“We are proud of our León team and to add another successful inspection to our long track record of compliance,” added Shawn Cain, chief operating officer, LSNE, in the press release. “As we continue to grow, quality is always at the forefront of our business so that we can best serve our clients and their patients. It is only through the hard work and dedication of our team that we have been able to achieve and maintain this high level of integrity, quality, and consistency.”