Lifecore Biomedical calls warning letter unwarranted, unfair.On Oct. 29, 2004, Lifecore Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. , Inc., Chaska, MN, responded to FDA's Oct. 8 warning letter [See Vol. XII, No. 19, page 9, Doc. 13308W] regarding its Intergel Adhesion Prevention Solution. The company stated that it believed the issuance of the warning letter was "unwarranted and unfair." First, the company noted that it disagreed with the agency's claim that the complaints listed in the warning letter should have been reported as MDRs, because the company said it complied with the applicable reporting obligations for each complaint. The company also said that it believed FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. failed to follow the definition of "malfunction mal·func·tion v. 1. To fail to function. 2. To function improperly. n. 1. Failure to function. 2. Faulty or abnormal functioning. ," because the device was used outside of its intended use for two of the complaints. Additionally, Lifecore pointed out that every complaint had been submitted to FDA in reports to the PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy file prior to the May 2004 inspection, and that the company had even received guidance from CDRH CDRH Center for Devices and Radiological Health (US FDA) officials on whether/ how to submit the complaints to FDA. The response letter explained that Lifecore had consulted with and updated the agency on a regular basis regarding four of the complaints at issue, and FDA had never directed the company to submit the complaints as MDRs. The company's letter further explained that the firm had requested an in-person meeting to discuss the agency's expectations, but that the agency had only allowed a teleconference on Sept. 2, 2004, during which the company claimed they did not receive adequate guidance or information. The firm asserted that the agency's letter contained six complaints that were not included in the 483 or in the teleconference. Lifecore concluded by stating that it will implement several corrective actions to resolve the matter, to include that: (1) it will submit the 13 cited complaints as MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. reports; (2) it will amend its general SOP for MDR reporting to clarify that the SOP will apply to all complaints received after the date of product approval; (3) it will implement a new SOP specifically for Intergel complaints and will submit this SOP to FDA by Nov. 12, 2004; and (4) the company will engage an outside consultant (a) to assist in revising the general SOP for MDR reporting and implementing the SOP specific to Intergel L reporting, and (b) to retrain re·train tr. & intr.v. re·trained, re·train·ing, re·trains To train or undergo training again. re·train Lifecore's MDR staff on the standards for MDR reporting and on the revised SOPS sop tr.v. sopped, sop·ping, sops 1. To dip, soak, or drench in a liquid; saturate. 2. To take up by absorption: sop up water with a paper towel. n. 1. . The agency responded to Lifecore's letter by saying that it disagreed with the company's characterizations of FDA's actions regarding a request for a meeting and teleconference. The agency stated that it believed it provided the company with the requested information about MDR requirements and said it would respond to the rest of Lifecore's letter as soon as possible. Doc. 13324W |
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