FDA WARNING_LETTER - R & B Medical Group Inc. - September 25, 2019

The FDA issued a Warning Letter to R & B Medical Group Inc., dba Universal Diagnostics Laboratories, following an inspection from September 16-25, 2019. The firm, a testing laboratory for human cells, tissues, or cellular or tissue-based products (HCT/Ps) used in donor eligibility determinations, was found to have significant deviations from 21 CFR Part 1271 regulations. Key violations include the failure to use appropriate FDA-licensed donor screening tests according to manufacturer instructions, specifically by misinterpreting and misreporting reactive screening results as non-reactive after confirmatory testing. The firm also failed to establish and maintain procedures for all testing, screening, and donor eligibility steps, including documentation of test kit lot numbers, equipment, incubation times, and reporting. Further deficiencies involved the lack of established procedures for complaint review and investigation, and for maintaining a quality program to investigate and document HCT/P deviations and trends. Additionally, the firm failed to maintain accurate, concurrent, and complete records for testing steps. The FDA emphasized that negative confirmatory tests do not override positive screening tests, citing 21 CFR 1271.80(d) and guidance documents. The firm is required to conduct a retrospective review of all misreported screening test results, notify affected clients, and implement prompt corrective actions within fifteen working days to prevent recurrence. Failure to comply may result in further regulatory action.