§ 429.60 - Records of distribution.

(a) The person to whom a certificate is issued shall keep complete records showing each shipment and other delivery (including exports) of each batch or part thereof, by the person requesting certification, and showing each such shipment and delivery into, or from any place in, any State or Territory, made by any person subject to his control, including records showing the date and quantity of each such shipment and delivery and the name and post office address of the person to whom such shipment or delivery was made.

(b) Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee of the United States, acting on behalf of the Secretary, the person to whom a certificate is issued, at all reasonable hours within 2 years after disposal of all the batch covered by such certificate, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such batch on hand and otherwise to check the correctness of such records.