Greiner Bio-One North America, Inc. – FDA EIR, Dec 13, 2019

An FDA inspection of Greiner Bio-One North America, Inc., a medical device manufacturer in Monroe, NC, was conducted from December 9-13, 2019. This follow-up inspection, under the regulatory framework for medical device manufacturers (21 CFR Part 820, Quality System Regulation), identified nine significant deficiencies, with some being repeat observations from a 2017 inspection. Key violations included the failure to complete validation testing for a new raw material supplier before product release and inadequate complaint handling, specifically not recording all device failures and failing to submit Medical Device Reports (MDRs) for serious incidents. The inspection also found issues with process validation, such as using uncalibrated injection molding machines and lacking validation for recycled resin. Furthermore, procedures for corrective and preventive actions (CAPA) were deemed ineffective, finished device acceptance tests did not conform to ISO standards, and equipment calibration schedules were not followed. Deficiencies in the quality agreement with the parent company and undocumented rationales for sampling plans were also cited. At the inspection's close, the company received a nine-item FDA-483, Inspectional Observations. Management committed to correcting all observations and was reminded of their responsibility to comply with the Federal Food, Drug, and Cosmetic Act to avoid potential enforcement actions.