A registrant shall notify the Board, within 14 days, in writing, of the following:

1. (1) any change in the d/b/a name of the entity accompanied by appropriate authorizing documentation;
2. (2) any change in the names of its officers or directors;
3. (3) any change in the ownership of the outsourcing facility representing more than 5% interest;
4. (4) an inspection by the FDA;
5. (5) receipt of an FDA Form 483 or Warning Letter; and
6. (6) any disciplinary or adverse action taken by the FDA or a state licensing or registering authority.