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This article was originally published in The Gray Sheet

Executive Summary

METREX TO COMPLETE GERMICIDE 510(k) DATA SUBMISSIONS TO FDA by mid-February, according to the company. Metrex submitted data on Metricide cold sterilant in early January and plans to send in data for Coldspore cold sterilant in the next several weeks. The documents are being submitted in response to a December 1991 agency request for additional information on a 510(k) covering both products. Metrex submitted the original 510(k) in April 1991. FDA had set a Dec. 11 deadline for submission of the data. In a Jan. 12 warning letter to the firm, FDA says that the 510(k) for the two products is "withdrawn" because the data was not submitted before the deadline. The device center's office of device evaluation considers the premarket approval notification for Metricide and Coldspore "to be withdrawn and therefore the continued marketing of these devices without an approved 510(k) is considered a violation of the Food, Drug and Cosmetic Act," the letter says. The agency adds that "continued marketing without an approved 510(k) may result in seizure and/or injunction without further notice." FDA withdrawal of the 510(k) follows the September 1992 court resolution of a law suit between the agency and Metrex over the agency's 1991 seizure of Metrex' disinfectant and sterilant products. As part of its decision, the U.S. District Court of Colorado rejected an earlier FDA assertion that the 510(k) was withdrawn because Metrex failed to submit the requested data ("The Gray Sheet" Sept. 21, p. 23). Metrex continues to market Metricide and Coldspore pending agency action on its 510(k) for the products. The company says it can legally market the germicides without FDA clearance because the court's September decision rejected FDA's argument that the products could not be distributed without agency action on the 510(k). Metrex says it responded to FDA's warning letter on Jan. 15, one day after receiving it. The company also met with officials from the agency's Denver district office the week of Jan. 25 to discuss steps it is taking in response to other deficiencies noted in the letter. In addition to addressing the status of Metrex' germicide 510(k), the warning letter cites Metrex for five violations of good manufacturing practices regulations. FDA alleges that Metrex failed to: "conduct adequate testing of your finished products under simulated conditions of use" "perform adequate functional testing or establish an adequate inspectional program for incoming components" "establish in-process controls and tests in order to assure the batch uniformity and integrity of your products and to validate the performance of your manufacturing processes" "properly calibrate equipment" and "implement an adequate quality assurance program." Metrex plans to conduct microbiological testing of its finished products and has developed a protocol for testing of components to address the first two deficiencies, according to the company. The firm also is modifying its standard operating procedures to correct equipment calibration problems. A final concern raised by FDA in the warning letter is Metrex' "action to withdraw all lots" of Coldspore from the market "and replace them with" an alternate sporicidin. FDA notes that its device center "categorized this as a Class II recall" which will be published in a future issue of FDA's enforcement report.

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