Contract sterilizer in U.K. hit on process validation.Contract sterilizer sterilizer /ster·i·liz·er/ (ster´i-liz?er) an apparatus for the destruction of microorganisms. ster·il·iz·er n. An apparatus for rendering objects aseptic. Griffith Micro Science of Derbyshire, UK, hosted an unnamed CDRH CDRH Center for Devices and Radiological Health (US FDA) investigator and wound up with a July 24 warning letter citing the firm for process validation activities that the agency deemed "inadequate in that they were not performed for worst-case conditions as required" by one of the firm's validation protocols The warning letter detailed that "process validation was performed for surface 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). and did not include the [redacted] material." 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. wrote also that the corrections proposed in the company's June 15 letter were inadequate because Griffith had not implemented them and that the agency may resort to detention of the firm's products. Doc. 9215W |
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