Assignment summary
- Mode key
- unknown
- Evidence excerpt
- Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufatured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.
- Rule explanation
- A recall reason is available, but none of the published named rules supports a failure-mode interpretation.