FDA EIR - Alexion Pharmaceuticals, Inc. - July 21, 2017

An FDA inspection of Alexion Pharmaceuticals, Inc.'s Smithfield, RI manufacturing facility took place from July 17 to July 21, 2017. Conducted under current Good Manufacturing Practices (CGMP) guidelines and specific FDA policies for drug and biological therapeutic product manufacturing, the inspection focused on the Quality, Facilities and Equipment, and Production systems for the non-sterile bulk drug substance Eculizumab. The inspection uncovered critical deficiencies, leading to an FDA Form 483. Main observations included inadequate maintenance of equipment and premises. Specifically, discoloration (rouging) was noted on product-contact surfaces of tanks without adequate inspection and preventive programs, and previously identified rouging was not remediated within established timelines, impacting commercial product manufacturing. Additionally, discoloration on a HEPA grate in a media preparation room was not properly documented or addressed. The report also cited insufficient facility maintenance to prevent pest contamination in aseptic controlled areas, referencing pest sightings in an ISO 7 room. Alexion's management acknowledged the observations, committing to a formal written response within 15 business days. A draft procedural revision to enhance visual inspections of equipment surfaces was presented during the inspection.