Section 22-B10723. GENERAL REQUIREMENTS

 

10723.1All records required by this chapter shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of the Department designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by Department employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

 

10723.2Records that the manufacturer deems confidential may be marked to aid the Department in determining whether information may be disclosed as public information.
 

10723.3All records required by this chapter shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two (2) years from the date of release for commercial distribution by the manufacturer.
 

10723.4This section does not apply to the reports required by § 10702.3 Management review, § 10703 Quality audits, and supplier audit reports used to meet the requirements of § 10707.1 Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of the Department, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required in this chapter, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).