21 C.F.R. § 80.39 – Records of distribution.

(a) The person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee acting on behalf of the Secretary of Health and Human Services, such person, at all reasonable hours until at least 2 years after disposal of all such color additive, 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 color additive on hand and otherwise to check the correctness of such records.
(b) The records required to be kept by paragraph (a) of this section shall show:
1. (1) Each quantity used by such person from such batch and the date and kind of such use.
2. (2) The date and quantity of each shipment or delivery from such batch, and the name and post-office address of the person to whom such shipment or delivery was made.
(c) The records required to be kept by paragraph (a) of this section shall be kept separately from all other records.