XBiotech Completes Successful FDA GLP Inspection

XBiotech was subject to a surprise U.S. Food and Drug Administration (FDA) inspection for good laboratory practices (GLP). From September 16, 2024 through September 19, the FDA conducted an inspection as part of FDA's Bioresearch Monitoring Program to ensure that the information submitted by XBiotech to the FDA was scientifically valid and reliable in accordance with Title 21 of the Code of Federal Regulations (CFR), Part 58 - Good Laboratory Practice (GLP) regulations. The inspection was unannounced and for several days the inspectors were reviewing XBiotech Quality Systems: Standard Operating Procedures (SOPs), Protocols, Animal Facility, personnel training etc. was reviewed. Norma Gonzalez, commented, "We are pleased to successfully pass the FDA inspection and proud of our team of scientists that adhere to stringent GLP guidelines and Quality Systems. The successful inspection indicates the commitment of XBiotech to comply with the FDA regulations while it pursue development of breakthrough medicines.