Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter X - LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
Section 229.443 - Enforcement and Penalties

Universal Citation: 25 TX Admin Code § 229.443

Current through Reg. 50, No. 13; March 28, 2025

(a) Inspection.

(1) To enforce these sections or the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), the Commissioner of the Department of State Health Services (commissioner), 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 a 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 vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of these sections or the Act.

(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 these sections or the Act.

(3) An inspection under paragraph (2) of this subsection 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 the Act; or

(E) research data other than data:
(i) relating to devices; and

(ii) subject to reporting and inspection under regulations issued under §519 or §520(g) of the Federal Food, Drug, and Cosmetic Act, as amended.

(4) An inspection under paragraph (2) of this subsection shall be started and completed with reasonable promptness.

(b) Receipt for samples. 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.

(c) Access to records.

(1) A person who is required to maintain records referenced in these sections or under the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or §519 or §520(g) of the Federal Food, Drug, and Cosmetic Act or a person who is in charge or 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 and to copy and verify the records.

(2) A person who is subject to licensure under these sections of this subchapter shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to and 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.

(d) Retention of records. Records required by these sections of this subchapter shall be maintained at the place of business or other location that is reasonably accessible for a period of at least 2 years following disposition of the device unless a greater period of time is required by laws and regulations adopted in § 229.432 of this title (relating to Applicable Laws and Regulations).

(e) Adulterated and misbranded device. If the Department of State Health Services (department) identifies an adulterated or misbranded device, the department may impose the applicable provisions of Subchapter C of the Act including, but not limited to: detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and/or administrative penalties. Administrative and civil penalties will be assessed using the Severity Levels contained in § 229.261 of this title (relating to Assessment of Administrative or Civil Penalties).

Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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