Title: Section 58-4.4 - Enforcement

58-4.4 Enforcement

(a) Registration under this Subpart may be denied, suspended, revoked or annulled by the department upon a determination that a registrant:

(1) failed to comply with the requirements of this Subpart; 

(2) provided services that constitute an unwarranted risk to human health; 

(3) intentionally provided any false or misleading information to the Department relating to registration or performing donor eligibility and collection procedures; or 

(4) has demonstrated incompetence or shown consistent errors in the performance of donor eligibility or collection procedures. 

(b) A registration shall not be suspended or revoked without a hearing. However, a registration may be temporarily suspended without a hearing for a period not to exceed thirty (30) days upon notice to the registrant following a finding by the Department that the public health, safety or welfare is in imminent danger.

(c) Source plasma donation centers shall provide the Department with immediate access to all registered facilities during reported operating hours, equipment, records, and personnel, as required by the Department to determine compliance with this Subpart and compliance with federal requirements in the Code of Federal Regulations, including Title 21, Parts 630 and 640 and Title 42, Part 493.