SECTIONS 1613-1615 - California Statutes

HEALTH AND SAFETY CODE

SECTION 1613-1615

1613. Applications for licenses issued under this chapter shall be
made upon forms issued by the department. The applications shall
contain at least the following:
(a) The name and address of the person owning the place,
establishment, or institution in which biologics production is
planned.
(b) The name and address of the person to be in charge of
biologics production.
(c) The types of biologics to be produced.
(d) A full description of the building, its location, facilities,
equipment, and apparatus to be used in biologics production.
(e) The name and address of each blood collection center operated
by the applicant and whether the applicant operates any mobile units.
(f) Any additional information as the department may require.

1614. If the department does not within 60 days after the filing of
the application issue a license, it shall state the grounds and
reasons for its refusal in writing, serving a copy upon the
applicant.
The notice may be served by registered mail addressed to the
applicant at his last known address.

1615. (a) A license shall be automatically revoked when there is a
change of address, ownership, or person in charge of biologics
production. However, a new license may be secured for the new
location, owner, or person in charge prior to the actual change if
the contemplated change is in compliance with all the provisions of
this chapter and regulations pertaining thereto.
(b) Proceedings for denial of license shall be conducted in
accordance with Section 100171.