LSNE Completes FDA Inspection

January 9, 2014
BioPharm International Editors

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.

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