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.