WARNING LETTER
Randox Laboratories Limited was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 696569
30 Randalstown Road
Antrim BT41 4FL
United Kingdom
Dates: August 5, 2024 through August 8, 2024
Inspection Issue(s):
The report states that “the RX series test systems, including the RX daytona, the RX daytona + (plus), and the RX imola test systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.”
- Failure to adequately establish and maintain procedures for validating device design, including appropriate risk analysis, as required by 21 CFR 820.30(g). For example, your firm has initiated five Class II Recalls, beginning in 2018 (Event IDs 81746, 86236, 91097, 92650, 93775), related to assay reagents from the previously used assays carrying over to the subsequent assay test, which caused erroneous results of the subsequent assay conducted on your RX series analyzers, including RX daytona and RX imola.
- Your firm also provided Risk Management Report for RX Series Analyzers – Automated RX modena, RX daytona+, RX daytona, RX imola, RX monaco, dated September 30, 2024 and Risk Analysis for RX Series Analyzers – Automated, revision number 4, approved on September 30, 2024. A carryover and contamination category was added to analyzer risk analysis. The risk evaluation before (b)(4).” However, no information was provided to support (b)(4) as required by RQA-1707.
- Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, CAPA NCP INC612, was initiated on October 16, 2023, due to a customer complaint related to issues when running Copper assay on a RX daytona + analyzer. Your firm confirmed the testing of total protein carried over to the subsequent copper assay, causing falsely elevated Copper results. The root cause description states, “Carryover from both cuvettes and pipettes,” but fails to identify the underlying cause of why the reagent from the previously used assay carried over to the subsequent assay.
- The bulletin currently includes a list of over 50 combinations of assays to avoid running in sequence. CAPA #NCP INC612 fails to identify the action(s) needed to correct and prevent recurrence of carryover of assays run on the RX series analyzers. Additionally, activities to ensure the effectiveness of the corrective actions were not identified. Your firm states “Confirm no further complaints since bulletin” but fails to verify or validate the corrective and preventive action to ensure that such action is effective.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
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