D.C. Mun. Regs. tit. 22, r. 22-B1501

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1501 - INSPECTIONS

1501.1

An inspection shall be carried out by an inspector from the Department's Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division or other employee authorized by the Act or the Director.

1501.2

The inspector prior to entry shall do the following:

(a) State the purpose of his or her inspection to the owner, operator, agent or other person in charge of the premises to be inspected; and

(b) Present appropriate credentials to the owner, operator, agent or other person in charge for making the inspection.

1501.3

Appropriate credentials for the making of the inspection shall include, but are not limited to, the following:

(a) Duly issued identification card, badge, etc., of the Department for the inspector;

(b) Notice of inspection issued by the Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division containing the following:

(1) The name and title of the owner, operator, agent or other person in charge of the premises;

(2) The controlled premises name;

(3) The controlled premises address to be inspected;

(4) The date of the inspection;

(5) The findings from the inspection; and

(6) The signature of the inspector.

(c) An administrative inspection warrant when required by § 505(b) of the Act.

1501.4

Any person to whom a registration or exemption has been issued shall retain copies of Inspection Reports and Violation Notices issued by the Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division or designees, and shall maintain the reports or notices on the registered premises in a manner so as to make them available upon request of the Director or inspector for a period of at least two (2) years.

1501.5

It shall be the duty of the Chief Pharmaceutical Control Officer or his or her designee to investigate a complaint of a violation of any provisions of the Act or this chapter.

1501.6

No person shall hinder, obstruct, or in any way interfere with the Chief Pharmaceutical Control Officer or his or her designee in the performance of official duty in carrying out the provisions of the Act or this chapter or any other applicable law or regulations.

D.C. Mun. Regs. tit. 22, r. 22-B1501

Final Rulemaking published at 33 DCR 1046, 1079 (February 21, 1986)