Revocation of an order to withdraw a qualified facility exemption.

21 C.F.R. § 117.280
in effectEffective: 2024-07-01
Sign in to generate a plain English summaryAsk Belisarius Agent
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.

Starting a business? Corpus forms LLCs in all 50 states and DC.