SECTION .0300 ‑ INSPECTION AND RECORD KEEPING

02 NCAC 52G .0301         INSPECTIONS

(a)  Upon receipt of an application for a license to produce biologics and the appropriate application fee, the director or his authorized agent shall inspect the establishment.

(b)  An authorized representative of the Commissioner shall be permitted to enter an establishment producing registered biologics at any reasonable hour and inspect without previous notification the entire premises of such establishment and all records maintained relative to the condition of animals maintained, biologic production, spoilage, and distribution, as well as any other premises where the registrant may have placed any such products, records, or animals.

(c)  The licensed manufacturer shall provide upon request and without cost to the Commissioner samples of stock cultures, other material, or finished product from his establishment and all firms or persons storing or selling the manufacturer's registered biologics; and shall also provide in contracts with distributors that the Commissioner may take such samples without charge to the Commissioner.

History Note:        Authority G.S. 106‑712; 106‑713;

Eff. April 1, 1984;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.