FDA WARNING_LETTER - Greiner Bio-One North America, Inc. - December 13, 2019

The FDA conducted an inspection of Greiner Bio-One North America, Inc. (Monroe, NC) from December 9-13, 2019, identifying significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803) for their Vacuette brand blood collection tubes. The devices were deemed adulterated under section 501(h) and misbranded under section 502(t)(2) of the Act. Key QS deficiencies included failures in design change procedures, complaint handling, process validation, corrective and preventive actions (CAPA), finished device acceptance, equipment maintenance, supplier controls, and statistically valid sampling plans. A critical MDR violation involved failing to submit a timely report for a device malfunction that could cause serious injury if it recurred. The firm submitted two responses outlining CAPAs, but the FDA found them inadequate, noting that corrections were in progress and lacked sufficient documentation or evidence of implementation and effectiveness. The FDA requires prompt action to correct all violations within fifteen business days, including systemic problem resolution and a timetable for ongoing actions. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, denial of Class III device approvals, and refusal of Certificates to Foreign Governments. The letter emphasizes that the listed violations may indicate broader quality management system issues.