Lyophilization Services of New England, Inc. (LSNE) Passes Comprehensive FDA Inspection

Manchester, NH – LSNE, a premier contract manufacturer specializing in aseptic fill/finish and lyophilization of both drug and medical device products, recently completed a week-long, comprehensive Food and Drug Administration (FDA) Audit of its medical device manufacturing facility. The successful completion of this audit for which no 483 citations were issued, demonstrates LSNE’s continued commitment in offering its clients quality cGMP manufacturing services.

LSNE has sustained positive corporate growth while maintaining the regulatory standards for both medical device and drug manufacturing; including the recent completion of an FDA Pre-Approval Inspection (PAI) and Compliance Audit for an Abbreviated New Drug Application (ANDA) for a sterile-injectable drug product at its Bedford, NH fill/finish facility.

For additional information or a sample copy, Contact: Claudio Tracanna, 25 Commerce Drive, Bedford, NH 03101, 603-668-5763 x241, ctracanna@lyophilization.com

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