Utah Admin. Code R70-640-3 - Registration Process-Manufacturing Facility

(1) Any manufacturing facility that seeks a GMP certificate shall register with the department.

(2) To register with the department, each applicant shall submit an application form to the department.

(a) A new registration is needed within 60 days of an ownership change.

(b) Registration is non-transferable.

(c) Manufacturing facilities that register after November 1 will be registered for the rest of that year and the following calendar year.

(3) The applicant shall:

(a) be an owner or legal representative of the manufacturing facility;

(b) comply with this rule and other applicable laws;

(c) agree to allow the department to have access to the manufacturing facility during normal business hours;

(d) provide requested information to the department; and

(e) pay the applicable registration fee when the application is submitted.

(4) Registration fee.

(a) Registration fees shall be paid for each application pursuant to Subsection 4-2-801(4).

(b) The manufacturing facility classification shall determine registration fees. The manufacturing facility classification is determined by the inspectable square footage of the manufacturing facility and the number of employees.

(c) Fees paid are nonrefundable.

(d) If a registration is suspended or revoked, no part of the fees paid for registration shall be returned to the owner or operator of the registered manufacturing facility.

(5) The application for registration shall include:

(a) the name, billing address, business telephone number, and signature of the applicant applying for the registration;

(b) the name of the manufacturing facility, federal tax identification number, physical location address, billing address, list of products being manufactured, square footage of the manufacturing facility, and the number of employees;

(c) information specifying whether the manufacturing facility is owned by an association, corporation, individual, partnership, or other legal entity; and

(d) a statement signed by the applicant that attests to the accuracy of the information provided in the application and agrees to provide other information as needed by the department.

(6) Before registration is issued, the department shall inspect the manufacturing facility to determine if the applicant complies with good manufacturing practices.

(a) If the result of the inspection shows compliance with good manufacturing practices the manufacturing facility shall be considered in good standing.

(b) If the inspection shows non-compliance with good manufacturing practices the manufacturing facility will not be considered in good standing and registration will be denied.

(c) Each registered manufacturing facility shall be inspected annually to keep the registration in good standing.

(7) The owner or person in charge of the manufacturing facility shall have the registration available for review upon request.

(8) The owner of a manufacturing facility may display the current annual registration.

(9) The department shall issue a registration after:

(a) a properly finished application is submitted, reviewed, and approved by the department;

(b) an inspection shows that the manufacturing facility is in good standing and complies with this rule; and

(c) the appropriate fees are paid.

Notes

Utah Admin. Code R70-640-3

Adopted by Utah State Bulletin Number 2023-06, effective 2/27/2023