§ 117.280. Revocation of an order to withdraw a qualified facility exemption.
137 words·~1 min read·
/us/cfr/t21/s§ 117.280A 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 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.