---
kind: "section"
citation: "21 C.F.R. § 117.280"
title: "21"
number: "117.280"
heading: "Revocation of an order to withdraw a qualified facility exemption."
url: "https://uscodex.org/cfr/21/117.280"
---

# §117.280. Revocation of an order to withdraw a qualified facility exemption.


An order to withdraw a qualified facility exemption is revoked if:

- (a) You appeal the order and request an informal hearing, FDA grants the request for an informal hearing, and the presiding officer does not confirm the order within the 10-calendar days after the hearing, or issues a decision revoking the order within that time; or
- (b) You appeal the order and request an informal hearing, FDA denies the request for an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time; or
- (c) You appeal the order without requesting an informal hearing, and FDA does not confirm the order within the 10-calendar days after the appeal is filed, or issues a decision revoking the order within that time.

## Notes

### 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.