---
kind: "section"
citation: "21 C.F.R. § 117.257"
title: "21"
number: "117.257"
heading: "Contents of an order to withdraw a qualified facility exemption."
url: "https://uscodex.org/cfr/21/117.257"
---

# §117.257. Contents of an order to withdraw a qualified facility exemption.


An order to withdraw a qualified facility exemption under [§ 117.5(a)](/cfr/21/117.5.md?p=a) 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 food manufactured, processed, packed, or held at such facility.
- (d) A statement that the facility must either:
  - (1) Comply with subparts [C](/cfr/21/subpartC.md) and [G](/cfr/21/subpartG.md) 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 [§ 117.264](/cfr/21/117.264.md).
- (e) A statement that a facility may request that FDA reinstate an exemption that was withdrawn by following the procedures in [§ 117.287](/cfr/21/117.287.md);
- (f) The text of [section 418(l)](/cfr/21/418.md?p=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](/cfr/21/part16.md) of this chapter, with certain exceptions described in [§ 117.270](/cfr/21/117.270.md);
- (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 Office of Compliance in the Center for Food Safety and Applied Nutrition); and
- (i) **The name and the title of the FDA representative who approved the order.**

## Notes

### Amendments

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016; 85 FR 16553, Mar. 24, 2020]

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.

### Amendments

[80 FR 56145, Sept. 17, 2015, as amended at 81 FR 3716, Jan. 22, 2016; 85 FR 16553, Mar. 24, 2020]