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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B4. DRUG MANUFACTURE AND DISTRIBUTION |
Section 22-B413. INSPECTIONS
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413.1The Director shall conduct an on-site inspection of an applicant’s facility before a license is granted.
413.2Applicants and licensees shall permit the Director or any authorized District official to enter and inspect their premises and delivery vehicles, and audit their records and operating procedures at any reasonable hour and in a reasonable manner.
413.3Applicants and licensees shall permit the Director to have access to all records, policies and procedures, contracts, and any other information that the Director deems necessary to determine if the facility is in compliance with the Act, rules issued pursuant to the Act, or any other District law or Federal law applicable to the manufacture, distribution, or wholesale of drugs.
413.4The Director shall send a written report of the findings of the inspection to the applicant or licensee no later than fifteen (15) working days after the conclusion of the inspection.
413.5If the report states that there are deficiencies, the applicant or licensee shall correct them within the time period required by the Director.
413.6The Director may request written proof of correction of all deficiencies and may conduct a follow-up inspection to determine correction of the deficiencies after the applicant or licensee notifies the Director that the deficiencies have been corrected.
413.7The Director may deny or revoke a license if the deficiencies have not been corrected within the time period specified by the Director pursuant to § 414 of this chapter. The applicant may reapply for a license after the deficiencies are corrected by submitting a new application and fee in accordance with this chapter.