Section 21.09 - NotificationsA registrant shall notify the Board, within 14 days, in writing, of the following:
(1) 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.Adopted by Mass Register Issue 1305, eff. 1/29/2016.