Radiometer America, Inc., Westlake, OH, Oct. 12

Warning Letter Bulletin, Nov, 2006

During a March 10, 13-16, 22-24, April 4-6 and May 3-5, 11, 12 and 23-25 inspection of the medical device manufacturing facility, FDA determined Radiometer America was not in conformance with the current GMP requirements of the QS.

Violations included, but were not limited to, failure to investigate complaints involving the possible failure of a device to meet its specifications; and, failure to describe when and how failure investigations were conducted in its complaint-handling procedures. Specifically, of the 18 complaints reviewed by the investigator, three Techline Reports and six BAS Report had incomplete failure investigations.

FDA also cited the firm for failure to define and complete complaint-handling procedures to ensure that all complaints were evaluated to determine whether they should have been filed as a MDRs. Specifically, the agency said that Radiometer America's complaint-handling procedures did not have a mechanism for reviewing malfunctions to determine if a malfunction would have been likely to cause or contribute to a death, or serious AE or injury, if the malfunction would recur.

FDA said it will further analyze responses found in Radiometer America's June 5 letter, regarding complaint handling, during the next FDA inspection of the facility.

Meanwhile, the FDA inspection also revealed that the manufacturer's blood gas analyzer devices were misbranded for the following reasons. Radiometer America failed to submit a written report to FDA regarding the correction the firm made to the capillary end-caps. On March 22, the firm sent a recall letter, accompanied by a bag of new end-caps, to customers who owned a Radiometer blood gas analyzer. The letter notified customers of a "leakage" problem with the capillary end-caps and asked them to discard all of the end-caps on hand. However, FDA pointed out, "This correction was initiated to remedy a violation of the Act caused by the device which may present a risk to health."

Radiometer America failed also to submit a written report to FDA regarding the correction it made to the waste tubing accessories used with its ABL 700/800 Blood Gas Analyzer devices. FDA regulations require manufacturers and importers to submit a written report to FDA of any correction or removal of a device if the correction or removal was initiated to reduce a risk to health posed by the device.

FDA acknowledged that Radiometer America's June 5-response letter stated the firm has revised its Corrections and Removals Procedure so that they require all recalls, including Class III recalls, are reported to FDA.

The agency said it will evaluate the adequacy of this response during the next FDA inspection of the facility as well. AE, C-H, MDR, QC/QS; Doc. 14019W