D.C. Mun. Regs. tit. 22, r. 22-B10210

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

Rule 22-B10210 - ENFORCEMENT AND PENALTIES

10210.1

To enforce the provisions of this chapter, the Department, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:

(a) Enter at reasonable times a place of business, including factory or warehouse, in which a device is manufactured, assembled, packed, or held for introduction into commerce or held after the introduction;

(b) Enter a vehicle being used to transport or hold a device in commerce; or

(c) Inspect at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicles and all equipment, finished and unfinished materials, containers, and labeling of any medical device and obtain samples.

10210.2

The inspection of a place of business, including a factory, warehouse, or consulting laboratory, in which a restricted device is manufactured, assembled, packed, or held for introduction into commerce extends to any place or thing, including a record, file, paper, process, control, or facility, in order to determine whether the device:

(a) Is adulterated or misbranded;

(b) May not be manufactured, introduced into commerce, sold or offered for sale under the Act; or

(c) Is otherwise in violation of the Act.

10210.3

An inspection under § 10210.2 may not extend to:

(a) Financial data;

(b) Sales data other than shipment data;

(c) Pricing data;

(d) Personnel data other than data relating to the qualifications of technical and professional personnel performing functions under this chapter; or

(e) Research data other than data:

(1) Relating to devices; and

(2) Subject to reporting and inspection under regulations issued under 21 U.S.C. §§ 360i or 360j of the act, as amended.

10210.4

An inspection under § 10210.2 shall be started and completed with reasonable promptness.

10210.5

An authorized agent or health authority who makes an inspection of a place of business, including a factory or warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner's or operator's agent a receipt describing the sample.

10210.6

A person who is required to maintain records under 21 U.S.C. §§ 360i or 360j or a person who is in charge of or has custody of those records shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to the records, and to copy and verify the records.

10210.7

A person who is subject to licensure shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times, access to all records, as well as to copy and verify all records showing:

(a) The movement in commerce of any device;

(b) The holding of any device after movement in commerce; and

(c) The quantity, shipper, and consignee of any device.

10210.8

Records shall be maintained at the place of business or other location that is reasonably accessible for a period of at two (2) years following disposition of the device unless a greater period is required by laws and regulations adopted in § 10201 of this subtitle (relating to Applicable Laws and Regulations).

10210.9

If the Department of Health identifies an adulterated or misbranded device, the Department may take or seek enforcement actions including, but not limited to:

(a) Detention;

(b) Emergency order;

(c) Recall;

(d) Condemnation;

(e) Destruction;

(f) Injunction;

(g) Civil penalties;

(h) Criminal penalties; or

(i) Administrative penalties.

D.C. Mun. Regs. tit. 22, r. 22-B10210

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

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.