FDA EIR - Lonza Bend Inc - January 24, 2020

An FDA Pre-Approval Inspection (PAI) was conducted at Bend Research, Inc. - Tumalo (BRIT) from January 21-24, 2020. This inspection, part of the regulatory review for New Drug Applications [b][4] and [b][4], focused on BRIT's operations as an analytical testing laboratory. The FDA identified two significant violations, documented on an FDA Form 483, pertaining to equipment performance and data integrity. Firstly, the company failed to ensure that its automatic and electronic equipment, specifically a critical [b][4] system (ID #01-0120), underwent routine inspection and checking according to a written program designed to assure proper performance. Recurring errors on this system, used for testing drug substances in registration batches, indicated that previous corrective actions had not addressed the root cause. Secondly, Bend Research, Inc. failed to maintain a comprehensive backup file for data entered into its computer systems. Critically, "LOG" information from the [b][4] software prior to October 2019 was unavailable, preventing a complete review of system errors, warnings, and operational data pertinent to analyses of registration batches. This deficiency hindered the FDA's ability to fully verify data integrity. The regulatory framework for this inspection was CPGM 7346.832 for Pre-Approval Inspections, with violations cited under 21 CFR 211.68(a) and 21 CFR 211.68(b). In response to these findings, the managing director committed to submitting a written reply within 15 business days. The FDA explicitly stated that failure to voluntarily correct serious conditions could lead to legal sanctions. The initial recommendation for the affected New Drug Applications was a "withhold".