LSNE Completes FDA Inspection

Article

LSNE completes an FDA inspection of its Manchester manufacturing facility.Lyophilization Services of New England (LSNE),

Lyophilization Services of New England (LSNE), a New Hampshire based contract-manufacturing organization, has completed an FDA inspection of its Manchester manufacturing facility. This is the sixth successful inspection of the site, which is currently functioning as a multiproduct medical device manufacturing facility. The November 2013 inspection was a combination FDA general GMP and pre-approval inspection. The inspection resulted in no Form 483 being issued, as there were no observations noted by FDA.

This FDA inspection follows a successful UK Medicines and Healthcare Products Regulatory Agency (MHRA) inspection of the LSNE 25 Commerce Drive, Bedford NH contract pharmaceutical manufacturing facility in which LSNE received a certificate of GMP Compliance from the MHRA to manufacture aseptic lyophilized drug products for use in the EU.

Source: Lyophilization Services of New England

 

Recent Videos
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Adam Sherlock, CEO of Qinecsa, discusses the changing political landscapes in the US and Europe and how that may affect the bio/pharma industry.
Adam Sherlock, CEO of Qinecsa Solutions
Related Content
© 2025 MJH Life Sciences

All rights reserved.