FDA WARNING_LETTER - Randox Laboratories Limited - August 08, 2024

On December 6, 2024, the FDA issued a Warning Letter to Mr. Steven Peter FitzGerald of 30 Randalstown Road, Antrim, United Kingdom, following an inspection from August 5-8, 2024. The inspection revealed that the firm's RX series test systems (RX daytona, RX daytona +, RX imola) are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately establish and maintain procedures for validating device design (21 CFR 820.30(g))**: The firm initiated five Class II Recalls since 2018 due to reagent carryover causing erroneous results. Despite a revised Risk Management procedure (RQA-1707), the firm has not conducted adequate risk analysis or identified sufficient control measures. Responses regarding updated risk management files and revised job descriptions were deemed inadequate, lacking supporting information, completion dates, or clarity on how changes prevent future failures. 2. **Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a))**: CAPA NCP INC612, initiated for a Copper assay carryover issue, failed to