1. (a) Current license. All establishments, except those exempt from licensing by law, shall be currently licensed by the department and shall be in substantial compliance with the Acts and the Rules as they apply to each specific type of operation.

2. (b) Current compliant inspection. All establishments shall have a current compliant inspection as follows:

   1. (1) manufacturers, distributors, or wholesalers of foods, dietary supplements, or drug products, within 12 months of application;
   2. (2) manufacturers, distributors, or wholesalers of cosmetic products, within 12 months of application;
   3. (3) manufacturers of medical devices, within 24 months of application;
   4. (4) distributors of medical devices, within 12 months of application;
   5. (5) producers, processors, and distributors of milk or dairy products, within 3 months of application; and
   6. (6) producers or distributors of molluscan shellfish, within 3 months of application.
3. (c) Violation. A certificate of free sale and sanitation and/or certificate of origin shall not be issued if substantive violations of the Acts or the Rules exist as determined by the department.

Source Note:The provisions of this §229.303 adopted to be effective March 15, 2001, 26 TexReg 2031.