FDA EIR - Greiner Bio-One North America, Inc. - October 29, 2021

An FDA inspection was conducted at Greiner Bio-One North America, Inc. in Monroe, NC, from October 25-29, 2021. This inspection served as a compliance follow-up to assess the effectiveness of corrective actions implemented in response to a Warning Letter issued on April 16, 2020. That Warning Letter stemmed from a December 2019 inspection, which identified nine significant issues, including inadequate design change control, deficiencies in complaint and Medical Device Reporting (MDR) processes, insufficient process validation, ineffective corrective and preventive action (CAPA) procedures, non-conforming finished device acceptance testing, outdated calibration of equipment, and poorly defined quality agreements and sampling plans. During the current inspection, conducted under CP7382.845 for medical device manufacturers, some progress on prior corrective actions was noted. However, new deficiencies were identified and listed on an FDA 483, Inspectional Observations. These included, under 21 CFR 820.100(a), continued inadequacies in CAPA procedures, specifically lacking established processes for cancelling CAPAs with complete data transfer, managing extension requests, and properly documenting immediate corrections and CAPA request forms. Furthermore, the company failed to establish clear training criteria for administrative access to its eCAPA system. Management was cooperative, acknowledged their responsibility to comply with the FD&C Act, and promised to provide a written response detailing corrective actions within 15 business days.