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This article was originally published in The Gray Sheet

Executive Summary

ALCIDE 510(K)S FOR EXSPOR AND LD DISINFECTING SOLUTIONS will be submitted to FDA by the end of June, the company says. Alcide currently is conducting tests that will generate data to support the 510(k) submissions. In a Feb. 26 warning letter, FDA cited the firm for failing to submit 510(k)s for the solutions, which are used primarily to disinfect surfaces in laboratories. The letter was released by the agency the week of March 22 (see box following story for list of all warning letters released during the week). FDA charged that Exspor and LD are misbranded because "a notice or other information respecting the devices was not provided to the FDA as required by Section 510(k) [of the Food, Drug and Cosmetic Act], and the devices were not found to be substantially equivalent to a predicate device." The warning letter, which is based on an inspection of Alcide's Norwalk, Connecticut facility on Oct. 30 and Nov. 4, 6 and 10, also lists several violations of good manufacturing practices regulations. Alcide says it responded to the warning letter on March 22 and believes it is now in compliance with all GMP regulations. The GMP problems cited by the agency include the failure to maintain "complete and current" device master records and "complete and accurate" device history records. FDA says that "the DMRs lack adequate production process specifications, packaging specifications and labeling specifications." The letter also notes that finished product testing was not performed for some lots, but "the DHRs for these lots have been signed off indicating that these tests were completed." In addition, the firm failed to "implement quality assurance (QA) procedures adequate to assure that a formally established and documented QA program is performed," according to FDA. Specifically, the facility's production records "are not reviewed," and "QA audits are not performed," FDA says. In addition, there is a "lack of written procedures for QA audits." Among other GMP violations cited in the letter is "failure to maintain written procedures for the control and distribution of finished devices to assure that only those devices approved for release are distributed." Alcide also failed "to maintain adequate controls to maintain labeling integrity and to prevent label mixups in that samples of labels are not proofread prior to release." Among other warning letters released the week of March 22 was one to Beiersdorf AG of Hamburg, Germany, a manufacturer of adhesive tapes, bandages and dressings. GMP deficiencies noted in the letter include failure to apply as stringent controls to specification changes as the firm did to original design specifications. Other GMP violations cited by FDA include "failure to have a formal approval procedure for any change in the manufacturing process of a device" and "failure to quarantine components prior to acceptance or to clearly identify them as not yet accepted." The letter also notes that the firm has not submitted 510(k)s for the products Cutifilm and Cutifilm Plus to the agency. A Feb. 8 warning letter to Phoenix Bioengineering of Bridgeport, Pennsylvania, a maker of several types of catheters and hydrocephalic valves and shunts, cites the firm for several GMP violations, including failure to assure that the release of its cruciform slit valves is consistent with the established criteria for their release. FDA points out that "15 lots of cruciform slit valve devices were tested for a period which exceeded specifications...[and] were accepted and distributed." In addition, FDA states that Phoenix has not complied with medical device reporting requirements in that "you failed to submit an MDR report to FDA" after receiving information about malfunctions that could lead to death or serious injury if they were to recur. For example, "there were alleged shunt valve malfunctions (two after implantation and one which the Quality Assurance Manager stated was 'MDR Reportable'), [that] should have been reported to FDA as malfunctions," the agency notes.



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