1. (a) Inspection.

   1. (1) To enforce these sections or the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), the Commissioner of Health (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:

      1. (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;
      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 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. (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:

      1. (A) is adulterated or misbranded;
      2. (B) may not be manufactured, introduced into commerce, sold, or offered for sale under the Act; or
      3. (C) is otherwise 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 other than shipment data;
      3. (C) pricing data;
      4. (D) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under the Act; or

      5. (E) research data other than data:

         1. (i) relating to devices; and
         2. (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. (4) An inspection under paragraph (2) of this subsection shall be started and completed with reasonable promptness.
2. (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.
3. (c) Access to records. 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.
4. (d) Adulterated and misbranded device. If the Texas Department of Health (department) identifies an adulterated or misbranded device, the department may enforce the applicable provisions of Subchapter C of the Act including, but not limited to: detention, emergency order, recall, condemnation, destruction, civil penalties, criminal enforcement, and/or administrative penalties, using the Severity Levels set out in §229.261 of this title (relating to Assessment of Administrative or Civil 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.