LSNE Completes FDA Inspection July 2016
Manchester, NH – Lyophilization Services of New England (LSNE), a New Hampshire based contract manufacturing organization is pleased to announce that the United States Food & Drug Administration (FDA) has concluded their most recent inspection of LSNE’s Medical Device facility located at 1 Sundial Avenue. This was a routine, general QSIT inspection and was the seventh successful inspection of this site. LSNE’s Sundial site is currently functioning as a multiproduct medical device manufacturing facility. The inspection was considered successful as there were no 483 observations cited by the FDA at the closeout.
Thomas McGrath, Vice President of Quality of LSNE stated, “We are very pleased with the result of the latest FDA inspection and the result of this inspection further demonstrates LSNE’s unwavering commitment to quality and patient safety.”
LSNE is a privately held company with six GMP facilities – four located in New Hampshire, one in Wisconsin and one located in León, Spain. LSNE has been providing contract lyophilization services to the pharmaceutical, biotechnology and medical device industries since 1997, specializing in a wide range of services including process cycle development, fill finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing. Through the thoughtful integration of six processing facilities, qualified staffing, and an extensive manufacturing history, LSNE is strategically positioned to provide products and services for clinical through commercial supply for pharmaceuticals and medical devices to a multi-national market.