10825. NOTIFICATION BY THE MANUFACTURER TO THE DEPARTMENT OF HEALTH

10825 NOTIFICATION BY THE MANUFACTURER TO THE DEPARTMENT OF HEALTH 10825.1 The notification to the Department required by § 10823.1(a) shall be confirmed in writing and, in addition to other relevant information which the Department may require, shall include the following: Identification of the product or products involved; The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture; The expected usage for the product if known to the manufacturer; A description of the defect in the product or the manner in which the product fails to comply with an applicable standard; An evaluation of the hazards reasonably related to defect or the failure to comply with the standard; A statement of the measures to be taken to repair such defect or to bring the product into compliance with the standard; (g) The date and circumstances under which the defect was discovered; and (h) The identification of any trade secret information which the manufacturer desires be kept confidential. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10825