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TAYLOR’s CIPROFLOXACIN INJECTION STERILITY TESTING DEVIATES FROM GMPS

Executive Summary

TAYLOR's CIPROFLOXACIN INJECTION STERILITY TESTING DEVIATES FROM GMPS and the company's proposed remedy for the problem "does not adequately address the deviations," FDA told contract manufacturer Taylor Pharmacal in a July 9 warning letter. Miles, which markets intravenous ciprofloxacin as Cipro IV, said Taylor is "only an alternate supplier" for the quinolone antibiotic and that most of the product is produced by Miles. The letter was signed by FDA Chicago District Office Director Raymond Mlecko. FDA inspected Taylor's Decatur, Ill. sterile facility from May 11 to June 2 of this year. The inspection revealed, among other violations, that "the bacteriostatic and fungistatic test performed on ciprofloxacin injection and gentamicin sulfate injection failed to grow all organisms as required by the USP sterility test procedure," the warning letter states. The gentamicin product being produced by Taylor is a generic version; Schering-Plough said Taylor is not a supplier of its Garamycin. Taylor responded to the inspection findings in a July 1 letter. FDA's July 9 response states that Taylor's proposed correction does not provide "assurances that the changes required to achieve successful bacteriostatic and fungistatic tests will be carried over to routine sterility testing of the products." FDA also said that "for a number of the observations, the response discusses actions that will be undertaken in the future. We cannot consider the response acceptable until the actions are accomplished and documentation provided." Taylor's parent company, the Abita Springs, La.-based ophthalmic drug-maker Akorn, said that Taylor had met with FDA Aug. 13 to discuss an appropriate response to FDA's inspection findings. Akorn said it felt all the issues had been sufficiently addressed and that it is awaiting another inspection by the agency. FDA's warning letter also cites Taylor for having "inadequate review in the evaluation of initial sterility positives." The agency said "there are no written procedures" to assure that investigations of initial sterility positives "include a documented review of all appropriate records and a thorough evaluation of the possibility of intrinsic contamination." Taylor's response to this deficiency "does not provide details of the investigations." Taylor was found to lack "established written procedures for conducting the annual review of production records for each drug product." FDA said that the company's response to the inspection findings "provides no details on how the annual product reviews will be conducted and no assurance that the reviews will meet the requirement of the Good Manufacturing Practice Regulations." Akorn bought Taylor in January 1991 as a replacement for its Walnut manufacturing facility in Los Angeles, which it closed in July 1991 following repeated recalls of Walnut-manufactured products ("The Pink Sheet" April 27, T&G-2). Before the acquisition, Taylor was solely a contract manufacturer of injectables, but it was expanded to accommodate some Akorn ophthalmic products. Taylor had a flurry of product recalls in 1988, including one Class I recall, all of which were due to inadequate assurance of sterility.
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