FDA 483 - Becton Dickinson, S.A. - October 27, 2022

An FDA inspection of Darbon Korborda, Inc., conducted from October 30 to November 2, 2023, identified significant deficiencies in the company's quality management system. The inspection, documented in a Form 483, highlighted two primary areas of concern that may indicate non-compliance with current Good Manufacturing Practices (cGMP). Firstly, the company's procedures for controlling environmental conditions were deemed inadequate. Specifically, the established alert limits, action limits, and corresponding references within their environmental monitoring protocols were insufficiently defined, indicating a lack of robust control over manufacturing environments. Secondly, the documentation of corrective and preventive action (CAPA) activities and their results was found to be incomplete. Multiple CAPA records lacked adequate documentation of completed corrective actions and associated investigations. This deficiency raises concerns about the company's ability to effectively identify, address, and prevent recurrence of quality issues, a fundamental requirement of a functional quality system under the Federal Food, Drug, and Cosmetic Act. Darbon Korborda, Inc. is expected to promptly evaluate these observations and implement comprehensive corrective actions to address the identified non-conformities, submitting a detailed response outlining their plan for regulatory compliance.