Warning Letter: Wrong software version was installed (ucm516914)

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Ofni Systems

During an inspection of your firm located at 3600 Gantz Road, Grove City, OHon various days between May 16 – June 28, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the initial importer, complaint handling unit, and repacker/relabeler of High Performance Liquid Chromatographs (HPLC) used in the measurement of hemoglobin, Automated Immunoassay Analyzers (AIA) used in the treatment of disease, and laboratory solutions, assays and test-cup reagents…

Over 15 Ticket Reports (non-routine service reports) reviewed by the FDA investigator document possible failures of AIA and HPLC analyzers. The Complaint section in your [redacted] database was not completed and Investigation Form, 10-QAG-015-2 was not initiated, as required by section 6.0 of your Complaint Handling procedure. For example: Ticket number 862-02-000256, dated 9/2/2015, states that the wrong software version was installed with the G8 analyzer; and Ticket number 001-00050034, dated 8/4/2015 states the customer was “Getting error message, and 338 as comm error” and ASM Board was replaced. No investigations were performed…

All sources of quality data are not being analyzed. Specifically…

You have not identified appropriate statistical methodology to be employed to detect recurring quality problems. Specifically…
The information entered into the Area/Category/Issue sections of your [redacted] database is not standardized and the Type is not always entered so the failure rate per part cannot be accurately calculated. As a result, you are not identifying failure rates per part that are above your thresholds for initiating a CAPA, as described in your “Trending Procedure”.

View the original warning letter.


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