§117.251. Circumstances that may lead FDA to withdraw a qualified facility exemption. — Inbound Citations

(c) If your exemption was withdrawn under § 117.251(a)(1) and FDA later determines, after finishing the active investigation of a foodborne illness outbreak, that the outbreak is not directly linked to your facility, FDA will reinstate your exemption under § 117.5(a), and FDA will notify you in writing that your exempt status has been reinstated.

(d) If your exemption was withdrawn under both § 117.251(a)(1) and (2) and FDA later determines, after finishing the active investigation of a foodborne illness outbreak, that the outbreak is not directly linked to your facility, FDA will inform you of this finding, and you may ask FDA to reinstate your exemption under § 117.5(a) in accordance with the requirements of paragraph (b) of this section.