Medical Device Daily Washington Editor

FDA warning letters occasionally nudge a firm out of the business of making devices or diagnostics, and such seems to have been the case in connection with the Jan. 23 warning letter to Mainline Technology (Ann Arbor, Michigan), which FDA inspected between July and August 2008.

The firm's president, Martha Mazurek, discussed a few aspects of the situation off the record, but for the record would only tell Medical Device Daily that the firm "has discontinued manufacturing and is not doing anything related" to the diagnostics cited in the warning letter. Mainline had been in the business for roughly two decades, she said.

The company made several tests for pregnancy which FDA states in the letter that Mainline had not cleared prior to commercial distribution. It is not clear from the letter whether the agency is referring to changes to existing diagnostics or to entirely new products for the company, but the agency acknowledged receiving an Aug. 15, 2008, letter from the company which stated "that you intend to discontinue manufacturing" and would instead "purchase these products exclusively from" suppliers with cleared versions of the diagnostics. FDA apparently issued the warning because the Aug. 15 letter "provided no evidence indicating that you have in fact done so, and your promises to comply with cGMP (current good manufacturing practices) requirements suggests that, to the contrary, you intend to continue manufacturing these products."

Many of the violations refer to lack of documentation of compliance with regulations, such as a citation that the company could offer "no evidence that you have established quality audit procedures or that quality audits have been performed." A similar citation regarding management reviews preceded it. On the other hand, FDA asserted that Mainline's employees "have not been trained" in manufacturing, testing, shipping and complaint handling for in vitro reagents, although the citation states that the company was able to document such training for one employee.

FDA also cited the company for lack of procedures governing quality requirements for contract manufacturers and lack of procedures for acceptance activities. Procedures for device history and device master records were said to be absent, which was also said to be the case for corrective and preventive action. However, the warning letter does not cite any problems with medical device reports.

Software firm cited for Part 11 lapses

The May 11 warning letter to R4 (Strongsville, Ohio) contained a laundry list of deviations from the quality systems regulations (QSRs) that suggested either a lack of familiarity with the QSR or a failure to document it's compliance activities, a task which itself is required.

The company, which writes software for ultrasound equipment used to monitor perinatal vital signs, was cited for lack of quality systems in broad terms, but FDA also alleged that "no employees in your firm are familiar with the requirements" of Part 820 "and no one has received training" for QSR requirements.

As might be expected, the list of omissions includes lack of design history files, lack of change controls, lack of complaint handling procedures, and lack of procedures for medical device reports. Ironically, the software firm was also cited for Part 11 lapses, including an electronic documentation system that purportedly lacked audit trails, system access limitations and electronic signatures.

Attempts to contact the firm were unsuccessful.

BD snared in FDA swine flu roundup

FDA also posted a number of warning letters addressed to firms attempting to market products that purportedly diagnose or treat swine flu, and a surprising addition to the list is Becton-Dickinson (Franklin Lakes, New Jersey), which the agency wrote up due to promotion of an unapproved diagnostic. The text of the warning suggested that someone with the firm's marketing department forgot that FDA and the Centers for Disease Control and Prevention are distinct agencies at the Department of Health and Human Services.

According to FDA, the diagnostics section of Becton's web describing the company's Directigen EZ flu test as one which "we are confident ... can detect this newer Type A, H1N1 flu virus," and that given that the test "detects the conserved portions of the influenza nucleoprotein, we understand from the CDC that in its view, there is no reason that our assay should not work to detect this flu virus."

FDA also cited the sponsor of the web site located at www.spilldepot.com for violative promotions of surgical masks purported to filter out the swine flu virus, H1N1, the same claim as was made at the web sites www.sunsetsurvival.com and www.novatechgadgets.com.