§ 507.65. Contents of an order to withdraw a qualified facility exemption.
356 words·~2 min read·
/us/cfr/t21/s§ 507.65·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
An order to withdraw a qualified facility exemption under § 507.5(d) must include the following information:
(a)The date of the order;
(b)The name, address, and location of the qualified facility;
(c)A brief, general statement of the reasons for the order, including information relevant to one or both of the following circumstances that leads FDA to issue the order:
(1)An active investigation of a foodborne illness outbreak that is directly linked to the facility; or
(2)Conditions or conduct associated with a qualified facility that are material to the safety of the animal food manufactured, processed, packed, or held at such facility.
(d)A statement that the facility must either:
(1)Comply with subparts C and E of this part on the date that is 120 calendar days after the date of receipt of the order or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or
(2)Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of § 507.69.
(e)A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in § 507.85;
(f)The text of section 418(l) of the Federal Food, Drug, and Cosmetic Act and of this subpart;
(g)A statement that any informal hearing on an appeal of the order must be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in § 507.73;
(h)The mailing address, telephone number, email address, fax number, and name of the FDA Division Director in whose division the facility is located (or, in the case of a foreign facility, the same information for the Director of the Division of Compliance in the Center for Veterinary Medicine); and
(i)The name and the title of the FDA representative who approved the order. [80 FR 56337, Sept. 17, 2015, as amended at 81 FR 3718, Jan. 22, 2016; 85 FR 16554, Mar. 24, 2020]