Dux Industries, Oxnard, CA, June 1 (Los Angeles).During a March 21 to April 10 inspection of the manufacturer of dental alginate alginate /al·gi·nate/ (al´ji-nat) a salt of alginic acid; water-soluble alginates are useful as materials for dental impressions. impression materials and temporary dental cement, 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. discovered that the devices were adulterated a·dul·ter·ate tr.v. a·dul·ter·at·ed, a·dul·ter·at·ing, a·dul·ter·ates To make impure by adding extraneous, improper, or inferior ingredients. adj. 1. Spurious; adulterated. 2. Adulterous. in that the methods used were not in conformance with GMP GMP (guanosine monophosphate): see guanine. requirements. Dux n. 1. (Mus.) The scholastic name for the theme or subject of a fugue, the answer being called the comes, or companion. was cited for failure of the management with executive responsibility to establish a quality policy; failure to establish a quality plan; and, failure to review the suitability and effectiveness of the QS at defined intervals and with sufficient frequency. Furthermore, FDA noted the firm had not established control procedures for conducting quality audits, nor had it established any internal audit plans for calendar years 2005 or 2006. Additionally, according to the warning letter, Dux neglected to establish and maintain procedures for implementing CAPAs and neglected to establish control procedures for receiving and evaluating complaints to ensure that all complaints were processed in a uniform and timely manner. Lastly, FDA pointed out that Dux had neglected to ensure that its merged corporate entities, which market under the Dux Industries brand name, followed GMP regulations for combination products. FDA said the investigation indicated that these business entities manufacture sterilization and disinfection disinfection, n the process of destroying pathogenic organisms or rendering them inert. disinfection, full oral cavity, n a procedure used to reduce active periodontal disease, usually completed within a certain short time frame. patient care items, namely sterilizing pouches and tissue management materials, and drug-impregnated dental braids, knits and cords; and, the drug-impregnated dental braid, knits and cords are deemed a combination product. FDA referred the company to the "Draft Guidance for Industry and FDA on Current Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. for Combination Products." In that document, the agency states that current GMP regulations for both sets of constituent parts of a combination product (e.g., drug and device) apply to the combination product. Specifically, FDA referred Aksys to page six of the document, in which the agency identifies key provisions of the current GMP and QS regulations that differ in their specificity and that should be carefully considered by combination product manufacturers to ensure compliance with both the current GMP and QS regulations. CAPA, C-H, Design, QC/QS; Doc. 13894W |
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