MEDICAL DEVICES.

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Bunnell Inc., Salt Lake City, UT, Oct. 29 (Denver). The letter stated that Bunnell did not analyze all sources of quality data, including sub-assembly rejects, and that audit schedules did not require examination of validation records and complaint files. FDA noted procedures for corrective/preventive action did not establish time frames for closure of corrective action reports and that "several" such reports had been open for over a year. The agency hammered Bunnell for failure to validate complaint-handling software, an ultrasonic sealing procedure, a leak-testing procedure and a ventilator burn-in process. Bunnell's incoming inspection records were said to be missing sampling plans and included incorrect lot sampling sizes. No acknowledgement of a response to the 483 was in the warning letter. Investigator Nicholas Nance inspected the maker of high-frequency jet ventilators Sept. 10-14. CAPA, QC/QS, Val

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Emergent Innovations, Indianapolis, IN, Oct. 30 (Detroit). The letter stated the firm conducted no quality audits and that device master records failed to: record review and approval; refer to component specifications; refer to a device history record; and describe quality assurance procedures and specifications. FDA alleged the firm's device history records did not include information on the date of device manufacture, the quantity manufactured and the quantity distributed and noted Emergent had no written plan for evaluation of complaints or "other reports of product malfunctions." The agency stated the company did not implement design control procedures for patient restraint devices and acknowledged a Sept. 6 response to the 483, but deemed the response inadequate to lack of documentation proposed corrections. Investigator Bernard Heidt inspected Emergent Aug. 6-17. C-H, Design, QC/QS

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GE OEC Medical Systems, Salt Lake City, UT, Sept. 28 (Dallas). The agency wrote that diagnostic X-ray equipment installed by GE at an undisclosed location exceeded the allowed limit for entrance exposure rates in automatic and manual exposure modes. FDA informed the firm it was liable for a refund to the purchaser, or repair or replacement at GE's cost, adding that if the noncompliance was due to normal wear and tear, "unwarranted" user abuse or improper maintenance/repair, GE was not responsible for correcting the noncompliance provided it could document the claim. The inspection of the equipment, which was installed May 30, took place Aug. 7.

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Medical Instruments Technology, St. George, UT, Aug. 8 (Denver). FDA cited the device reprocessor for failure to specify which catheters were employed in a validation of bioburden and total organic carbon removal and noted the firm could not produce validation documents related to evaluation of impedance, resistance and continuity testing of an unspecified device. The letter hit the firm for failure to "specifically identify and evaluate" sterilization in the design process and made the same comment regarding package inserts and labeling. The agency noted Medical Instruments did not document corrective and preventive action for two consumer complaints and noted that complaint files did not distinguish between brand or model of laparoscopic instruments. FDA stated the company lacked written procedures to ensure devices were not reprocessed more frequently than a purged number of times. The firm was also cited for storage of master control documents on computer systems which "allowed access to unapproved personnel," and for failure of management to review process controls. Investigator Ricki Chase-Off??? inspected Medical Instruments April 16-24. C-H, Design, QC/QS, Val

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Nipro Medical, Miami, FL, Oct. 16 (Florida). FDA cited the firm for failure to hold intact an undated shipment of latex examination gloves for a release notice and informed Nipro that redelivery had been requested of U.S. Customs. The agency inspected the available portion of the shipment Sept. 25.

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Ramco Labs, Stafford, TX, Oct. 16 (Dallas). The agency stated the maker of in vitro diagnostics had not established procedures for management review and that a quarterly audit checklist did not include audits of management, purchasing and document controls. FDA slapped the firm for failure to document justification for release of one lot of human transferrin receptor (TfR) assay kits which had out-of-range normal control values and for lack of documentation of systemic or statistical analysis of quality control test data and customer complaints. The letter alleged the firm did not conduct accelerated stability tests on an unnamed product after a change in conjugate and had no documentation justifying not reporting recall of two lots of the TfR assay kits. FDA acknowledged Ramco's Sept. 5 response to the 483 and noted that the Texas Dept. of Health issued the firm two warning letters for inspections in 1999. The unnamed FDA investigator inspected Ramco Aug. 22-24 and 28. QC/QS, Stab

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Sorenson Development, Salt Lake City, UT, Oct. 17 (Denver). FDA stated the infusion pump maker's quality assurance and quality control personnel did not have the authority to halt manufacturing for products not meeting specifications discovered during production. FDA added that Sorenson's corrective action report procedure failed to define sources of quality data such as "rework material, scrapped material, in process failures, finished product failures and engineering change orders." The letter alleged the company did not exhaustively revalidate software used in the "Palm Pump" following an April 2001 engineering change. FDA added Sorenson did not validate "computer and/or automated data processing system software" used in production and quality systems, including the use of electronic signatures. The firm was cited for gauges used in the quality assurance lab and in production which were beyond their calibration dates. FDA acknowledged Sorenson's Sept. 18, 2001 response to the 483, but complained it could not evaluate the response because no supporting documents were included. Investigator Ricki Chase-Off inspected the firm's plant in West Jordan, UT, Aug. 22- Sept. 4. CAPA, Cal, Comp/Soft, QC/QS, Val

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Surgical Instruments Service and Savings, Sisters, OR, Oct. 18 (Seattle). The letter alleged that validation of a sterilization process did not identify the devices being sterilized and disallowed determination of whether the "most difficult to sterilize devices" were included and that validation of a heat sealing procedure failed to identify the temperature at sealing. FDA purged the parameters in a citation for soak and ultrasound duration in a cleaning procedure that deviated from established parameters. The agency noted two obsolete procedures were found in a receiving department handbook and cited Surgical for lack of approval and implementation dates for eight procedures, two of which were said to include hand-written changes. FDA acknowledged the firm's Aug. 30 response to the 483 and informed Surgical that certificates for export and premarket submissions reasonably related to the deviations would be held pending corrections. Engineer Dennis Kawabata inspected the firm May 22-25. Ster, Val

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Wells Johnson Company, Tucson, AZ, Oct. 18 (Los Angeles). FDA's untitled letter did not list the deviations disclosed during the September inspection, but noted Wells' Sept. 25 response "has satisfied us that you either have taken or are taking appropriate corrective action." The agency acknowledged the firm's filing in U.S. Bankruptcy Court for the State of Arizona as well as the firm's intent to reduce its payroll and suspend some operations, and informed Wells that a resumption of operations would require reinspection. According to the letter, Wells produced "general and plastic surgery devices."