Artificial skin maker's processes, water cited.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. opened its letter to Culture Technology of Los Angeles with a citation for failure to obtain marketing clearance prior to offering its LikeSKIN (allograft allograft: see transplantation, medical. ) and LifeSKIN (autograft autograft: see transplantation, medical. ) for sale, but the April 19-28 inspection disclosed a couple of problems with validation of manufacturing processes. The Aug. 24 letter zapped Culture Technology for failure to validate the manufacturing process or the cell culture protocol for patients with known sensitivities for either product. The letter also commented that the sterility test method employed by the firm had not been validated "to demonstrate that [redacted] containing a graft is equivalent to testing the actual graft for sterility." In other very brief citations, the agency stated that Culture Technology had not validated its deionized water system or the autoclave autoclave Vessel, usually of steel, able to withstand high temperatures and pressures. The chemical industry uses various types of autoclaves in manufacturing dyes and in other chemical reactions requiring high pressures. sterilization sterilization Any surgical procedure intended to end fertility permanently (see contraception). Such operations remove or interrupt the anatomical pathways through which the cells involved in fertilization travel (see reproductive system). for equipment used in manufacturing. Also listed as having not been qualified were: * The drying oven and oven vacuum. * Four cell growth incubators. * Two cell storage tanks. * An autoclave (it is not clear whether this is the autoclave mentioned in the previous citation). The letter acknowledged the firm's May 6 letter but described the proposed corrections as largely inadequate. Doc. 9141W |
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