MEDICAL DEVICES.

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Abbott Labs, Abbott Park, IL, Aug. 7 (Chicago). The letter cited the firm's Hospital Products Division's production of Plum XL infusion pumps for failure to submit a Report of Correction or Removal in connection with complaints regarding the device's alarm. FDA wrote that nurses had changed central line tubing in the devices in response to the alarms, "thereby increasing the infection rate" and that Abbott had issued a technical service bulletin in February to replace a spring in pumps already in use. The agency insisted that this met a criterion for a correction and hence should have been reported to the agency within 10 working days. Investigator Chad Schmear audited Abbott March 20-April 10. C-R

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Acon Labs, San Diego, CA, Aug. 18 (CDRH-OC). The warning letter hit the firm for promotion of a variety of test kits on its Web site because Acon had not obtained premarketing clearance nor submitted premarket notification to FDA. The products in question included test kits for hepatitis, syphilis, pregnancy, HIV, and marijuana and cocaine use. PMA, Web

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Dr. Alan Aker, M.D., Boca Raton, FL, Aug. 28 (CDRH-OC). The letter cited Aker's activities as a clinical investigator (CI) for including a subject in the study of an unnamed device who failed inclusion criteria and for failure to perform procedures as outlined in the study protocol including tests for contrast sensitivity, slit-lamp photography, pachymetry and corneal topography. The agency hit Aker for failure to record on case report forms information on pachymetry, uncorrected distance vision, cycloplegic refraction, patient comments of "cloudy on and off," and patient use of Patanol. The letter stated that Aker could not document any attempts to contact five subjects after missed ex-aminations and that Aker used an out-of-date consent form for one study subject. The letter stated that the CI enrolled one study subject prior to approval of the study by the institutional review board (IRB). Investigator Michelle Dunaway audited Aker Feb. 1-March 11. BiMo

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Ameritek, Seattle, WA, Aug. 24 (Seattle). FDA hit the firm for lack of premarket approval for its dBest One-Step HIV1/HIV2 test kits and for failure to obtain the agency's approval prior to exporting. The letter noted that Ameritek had not documented the disposition of nonconforming units and had not established complaint procedures. The inspection of Ameritek took place April 3-13. C-H, PMA

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The Cooper Health System, Camden, NJ, (CDRH-OC). The agency cited the IRB for applying expedited review procedures for "significant protocol amendments" for a device which was the subject of an IDE. The letter also cited Cooper for not including all informed consent elements in an unnamed study[ies] and to "ensure the prompt reporting of all serious adverse events including any deaths" in a study. FDA insisted that the IRB had failed to maintain adequate records, including those for protocol filing and periodic reports and for identification of board members' institutional commitments, knowledge of applicable regulations and identification of primary reviewers. The agency commented that it had documented similar deviations in a 1996 audit and "violations similar to those noted above persisted." Investigator Judith Jones handled the Feb. 22-March1 inspection of Cooper Health Systems. BiMo

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Diagnostica Stago, Parsippany, NJ, Aug. 18 (CDRH-OC). FDA hit the firm for using plasma that was tested for HIV and hepatitis with non-FDA approved kits in the production of several assay catalogs, including the STA Thrombin catalog and a fibrinogen assay catalog. The unnamed investigator reviewed the operations of Diagnostica April 26-May 17.

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Nobel Biocare, Goteborg, Sweden, Aug. 31 (CDRH-OC). The letter cited the maker of dental implants and dental surgical instruments for failure to implement and maintain an MDR procedure and deemed Nobel's products mis-branded due to a failure to report complaints for the Contra-Angle handpiece within the required time frame. The agency stated that a recall of the device was initiated because "of device fractures and the risk posed should the device fracture during surgery," rendering the recall subject to the 10-day rule for MDR, which FDA insisted Nobel failed to observe. The three-page warning letter commented that the company had failed to reference historical test data for a screw, but deemed it acceptable to update design control records with the historical data so long as design control procedures were amended to indicate when the use of historical data was permissible "in lieu of actual testing." The agency inquired as to how the company intended to head off "the type of device failure that occurred with the Contra-Angle handpieces" in the future. The agency audited Nobel May 22-26. CAPA, MDR

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Paradigm Medical Industries, Salt Lake City, UT, Aug. 30 (CDRH-OC). FDA cited the sponsor of a study of an unnamed device for failure to "adequately monitor the study" as indicated by a lack of documentation "that any of the study sites were monitored prior to January 2000." The letter expanded on the point by noting that "a review of the case report forms (CRFs) revealed numerous deviations" including enrolling subjects who had failed to meet inclusion criteria, follow-up visits that took place outside prescribed time frames and unreported adverse effects. The letter stated that Paradigm lacked documentation that "investigators or their personnel were trained in the use of the [purged], regarding the investigational plan or in how to complete the CRFs." The agency observed that "none of the individuals listed as monitors during the course of the study had previous experience with clinical trials and/or monitoring." FDA observed that Paradigm had "no documentation of the number" of investigational devices made and distributed, the number of copies of controlling software made or the disposition of each copy of the software. The letter stated that Paradigm's files contained no signed investigator agreements and that the investigation turned up adverse events which the firm failed to report to the agency. Paradigm was informed that a change to the investigational device called for a premarket notification and the letter commented that "your present plans to assume manufacturing responsibilities, originally contracted to [purged], may also require submission of a 510(k)." Investigator Margaret Annes handled the June 5 and 26 audit of Paradigm. 510(k), BiMo

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Taiwan Fuji Latex, Taipei, Taiwan, Aug. 28 (CDRH-OC). FDA alleged that the firm had conducted no formal validation of a testing process for condoms at the company's Tamshui plant despite the fact that Fuji performed "manual condom testing to confirm proper operation of the [purged]." The letter commented that daily challenge testing of the detection alarm was no substitute for validation and that SOPs for corrective/preventive action did not call for documentation of temperatures falling outside a specified range. The warning letter noted two such oc-currences. The agency complained that Taiwan Fuji had no data from long-term (90 day) accelerated aging or from real-time stability testing of its condoms to verify the claimed five-year shelf life" and informed the firm that FDA would consider the condoms misbranded as a consequence. The letter served notice that FDA would put the com-pany's condoms on detention and observed that Taiwan Fuji had never responded to a warning letter issued by FDA dated Feb. 25, 1999. An unnamed investigator audited the company June 12-13. CAPA, Stab, Val

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Teleflex, Plymouth Meeting, PA, Aug. 10 (Atlanta). The letter stated that Teleflex failed to forward information concerning complaints regarding its Blakemore tubes and Foley catheters to FDA. The agency insisted that Teleflex concluded that the "out-of-box" malfunctions were not reportable inasmuch as they did not affect patients. The letter stated that the firm promised investigator Fulton Varner that the firm would revamp the complaint decision chart, apply it retroactively and forward the results to FDA, but that the company had not done so at the time of the issuance of the warning letter. The letter noted further that Teleflex had not established that its Simplastic catheters would conform to product specifications throughout the projected five-year life and commented that a review of stability data used to justify the five-year expiration revealed "significant deficiencies." FDA acknowledged the company's July 5 letter but described the response as inadequate. The inspection of Teleflex took place June 19-29. MDR