FDA EIR - Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services - December 07, 2018

An FDA inspection of Lyophilization Services of New England, Inc. (LSNE), a contract manufacturer of sterile drug products, was conducted from November 20 to December 7, 2018. This comprehensive inspection, performed under Compliance Program 7356.002A for Sterile Drug Process Inspections, evaluated the company's Quality, Facilities and Equipment, Production, and Laboratory Control Systems across its Bedford, NH facilities. At the inspection's conclusion, LSNE received a four-item FDA Form 483, detailing significant observations. Key issues included the Quality Unit's failure to routinely evaluate and approve quality processes such as deviation investigations, CAPAs, and qualification activities within established timelines. The firm's water system design and its sanitization program were deemed inadequate. Furthermore, LSNE had not thoroughly investigated patient complaints concerning difficulties in opening drug product vials. Finally, the in-process sampling procedure for drug products in the formulation tank was found to be deficient, with an operator observed using improper aseptic technique. LSNE management acknowledged the observations and committed to submitting a written response to the agency within 15 business days, outlining corrective actions for these regulatory deficiencies.