247 CMR 21.09 - Notifications

A 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.

Notes

247 CMR 21.09

Adopted by Mass Register Issue 1305, eff. 1/29/2016.