Notifications

A registrant shall notify the Board, within 14 days, in writing, of the following: any change in the d/b/a name of the entity accompanied by appropriate authorizing documentation; (2) any change in the names of its officers or directors; (3) any change in the ownership of the outsourcing facility representing more than 5% interest; (4) an inspection by the FDA; (5) receipt of an FDA Form 483 or Warning Letter; and (6) any disciplinary or adverse action taken by the FDA or a state licensing or registering authority.