FDA EIR - Lonza Bend Inc - June 30, 2017

An FDA Good Manufacturing Practice (GMP) surveillance inspection was conducted at Bend Research, Inc.'s Control Testing Laboratory (BRIT) from June 26 to June 30, 2017. This five-day review, performed under the drug manufacturing compliance program, aimed to assess the facility's adherence to regulatory standards. Investigators identified several areas requiring improvement, leading to the issuance of an FDA Form 483. Key issues included inadequate segregation of GMP laboratory areas, allowing access by unauthorized personnel, and deficiencies in laboratory controls for in-process tests which did not meet USP standards or were not properly qualified against primary standards. Additionally, the Quality unit's procedures for handling deviations, reviewing Quality Control Laboratory Logbooks, and closing corrective and preventive actions were found to be either unwritten or not fully implemented. Notably, deficiencies cited in a previous inspection concerning data integrity, unvalidated spreadsheets, and system security had been successfully addressed and corrected. In response to the current observations, Bend Research, Inc. management committed to submitting a written reply to the FDA within fifteen business days, detailing their proposed corrective actions.