RICHARD WOLF HULKA CLIP APPROVAL BEING RECONSIDERED

RICHARD WOLF HULKA CLIP APPROVAL BEING RECONSIDERED, FDA says in a Nov. 4 warning letter following a May 20-July 7 inspection of the firm's Vernon Hills, Illinois facilities. "Because of problems associated with the Hulka clip," the agency "is reconsidering the conditional approval of [Richard Wolf's] application for premarket approval of the device." In 1988, FDA granted the device approval contingent upon postmarket studies, the firm says. FDA's concerns about the Hulka clip could have arisen at least in part from recent adverse event reports on the tubal occlusion device. A monthly-updated data base of adverse incident reports that have been sent to the agency lists 36 reports for the Hulka clip in June and 12 in October. Of the 48 adverse event reports, 27 were classified as malfunctions and 21 as serious injuries. Malfunctions ranged from clips that fell off the fallopian tubes to unintended pregnancies. Serious injures included severe lower abdominal pain and infections. The Hulka clip was also the subject of a 1991 warning letter that cited the firm for good manufacturing practices deficiencies ("The Gray Sheet" Aug. 26, 1991, p. 19). The firm is preparing its response to the warning letter. On Nov. 9, the manufacturer requested additional information from FDA as to why the agency is reconsidering the approval. Richard Wolf likely will reference in its response points made when it replied to an FDA 483 establishment inspection report that followed the audit. According to the company, issues raised in the warning letter all were addressed in the company's response to the 483. FDA's warning letter notes that the response to the 483 was "adequate." The warning letter alleges that device history records for the Hulka clip did not "include the control number designating each critical component used in manufacturing the device." The warning letter also addresses good manufacturing practices deficiencies associated with both Hulka clips and bipolar cables manufactured by the firm. "Investigations of complaints" regarding both devices, for example, "were not always conducted when product failed to meet performance specifications," FDA says. Richard Wolf did not validate changes to bipolar cables, nor did the firm test to assure that changed devices "conformed to [their] original design," the letter states. FDA also cites the firm, without referencing a specific device, for its "failure to prepare and implement a quality assurance program that consists of procedures adequate to assure approval or rejection of all components," materials, labeling and finished devices. In addition, FDA says, the firm did not "reject components not meeting established inspection criteria," nor did it "document disposition of all obsolete, rejected, or deteriorated components." The agency also maintains that the company did not make required medical device reporting (MDR) submissions for bipolar cables; four specific instances were listed in which reports should have been submitted but were not. The firm is to submit MDR reports for those incidents and "all other reportable incidents which were not reported to the FDA and that were received" up to two years before the warning letter. The firm is evaluating its adverse incident reports and expects to submit them the week of Nov. 29.