Question

If the FDA investigator issues a Form FDA 483 after an inspection, the clinical investigator should:

Answer 1

Answer:

If the FDA investigator issues FDA form 483 after an inspection, the clinical investigator should respond to the form in writing in less than 15 working days.

Explanation:

• The grounds for issuing an FDA 483 form are that there must be some violations of the Food Drug and Cosmetic Act found after the investigation done by the investigators.
• The management of the firm needs to clarify its stand in less than 15 days on the findings of the investigation that concluded in saying that there are apparent violations of the FD&C Act.