1. (a) General enforcement actions. The department may take enforcement action for the following:

   1. (1) failing to comply with Texas Food, Drug, and Cosmetic Act, HSC Chapter 431 (Act) or these sections;
   2. (2) falsifying information provided in an application for a license, or making a false or misleading statement in connection with the initial or renewal application, either in the formal application itself or in any other instrument relating to the application submitted to the department;
   3. (3) refusing to allow the department to conduct an inspection or collect samples;
   4. (4) interfering with the department in the performance of its duties;
   5. (5) removing or disposing a detained device;
   6. (6) misrepresenting any regulated product sold to the public; or
   7. (7) receiving a conviction of a misdemeanor that involves moral turpitude or a felony.

2. (b) Administrative penalty. If a person, whether licensed or unlicensed by the department, violates these sections or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person.

   1. (1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.
   2. (2) Violations subject to this subsection must be categorized into severity levels as determined in §229.261 of this chapter (relating to Assessment of Administrative Penalties).
   3. (3) An administrative penalty may be assessed only after the person charged with a violation is given an opportunity for a hearing.
   4. (4) If the person charged with the violation does not request a hearing, or defaults, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.
   5. (5) After making a determination under this subsection that a penalty is to be assessed, the commissioner must issue an order requiring that the person pay the penalty.
   6. (6) Not later than the 30th calendar day after the date of issuance of an order finding that a violation has occurred, the commissioner must inform the person against whom the order is issued of the amount of the penalty.

3. (c) Emergency orders.

   1. (1) The commissioner or a person designated by the commissioner may issue a mandatory or prohibitory emergency order, without notice, in relation to the manufacture or distribution of a food, drug, device, or cosmetic upon determination that: the manufacture or distribution creates or poses an immediate and serious threat to human life or health, and other procedures available to the department to remedy or prevent the occurrence of the situation will result in unreasonable delay.
   2. (2) If an emergency order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, must propose a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing must be held under departmental formal hearing rules governed by §§1.21, 1.23, 1.25, and 1.27 of this title.
   3. (3) The department must transmit the order in person or by electronic mail or by registered or certified mail to the license or registration holder. If the license or registration holder cannot be located for a notice required under this section, the department must provide notice by posting a copy of the order on the front door of the premises of the license or registration holder.

4. (d) Inspection.

   1. (1) To enforce these sections or the Act, the department or authorized agent may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:

      1. (A) enter, at reasonable times, a place of business, including a factory or warehouse, where a device is manufactured, assembled, packed, or held for introduction into commerce or held after the introduction;
      2. (B) enter a vehicle being used to transport or hold a device in commerce; or
      3. (C) inspect, at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicle, including 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. (2) The inspection of a place of business, including a factory, warehouse, or consulting laboratory, where a restricted device is manufactured, assembled, packed, or held for introduction into commerce may include any place or item, such as a record, file, paper, process, control, or facility, needed to determine whether the device:

      1. (A) is adulterated or misbranded;
      2. (B) is prohibited from being manufactured, introduced into commerce, sold, or offered for sale under the Act; or
      3. (C) is in violation of these sections or the Act.

   3. (3) An inspection under paragraph (2) of this subsection may not extend to:

      1. (A) financial data;
      2. (B) sales data, except for shipment data;
      3. (C) pricing data;
      4. (D) personnel data, except for data relating to the qualifications of technical and professional personnel performing functions under the Act; or

      5. (E) research data, except data that:

         1. (i) relates to devices; and
         2. (ii) is subject to reporting and inspection under regulations issued under the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i or §360j, as amended.
   4. (4) An inspection under paragraph (2) of this subsection must be started and completed with reasonable promptness.
5. (e) Receipt for samples. An authorized agent or health authority who inspects a place of business, including a factory or warehouse, and obtains a sample during the inspection must give to the owner, operator, or the owner's or operator's agent a receipt describing the sample before leaving the place of business.

6. (f) Access to records.

   1. (1) A person who is required to maintain records referenced in these sections, the Act, or the Federal Food, Drug, and Cosmetic Act, 21 United States Code §360i, or a person who is in charge or custody of those records must, upon request by an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of the records.

   2. (2) A person who is subject to licensure under these sections of this subchapter must, at the request of an authorized agent or health authority, provide access to the records, at all reasonable times, for copying and verification of all records showing:

      1. (A) the movement in commerce of any device;
      2. (B) the holding of any device after movement in commerce; and
      3. (C) the quantity, shipper, and consignee of any device.
7. (g) Retention of records. Records required by this subchapter must be maintained at the place of business or another reasonably accessible location for a period of at least two years following disposition of the device, unless a longer retention period is required by laws and regulations adopted in §229.432 of this subchapter (relating to Applicable Laws and Regulations).
8. (h) Adulterated and misbranded device. If the department identifies an adulterated or misbranded device, the department may impose the applicable provisions of Subchapter C of the Act, including detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and administrative and civil penalties. Administrative penalties will be assessed using the severity levels contained in §229.261 of this chapter (relating to Assessment of Administrative Penalties).

Source Note:The provisions of this §229.443 adopted to be effective October 18, 1994, 19 TexReg 7910; amended to be effective December 13, 1998, 23 TexReg 12353; amended to be effective March 19, 2001, 26 TexReg 2196; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective January 5, 2026, 51 TexReg 147.