The FDA field offices have primary responsibility for conducting inspections or investigations and collecting samples which may lead to recommendations for enforcement/regulatory action. The type of action recommended will depend upon the nature of the violation and the public health concern, Agency policy, previous history of violations by the firm, and other factors.

There are very serious consequences for violation of the FD&C. Typically this falls on management. But as an employee compliance with the FDA starts with you. When an inspection comes each company handles it in a different way, so it is important that you are aware of their policies so you know how to behave. Here are some general rules to help you as an employee.

- Answer questions honestly
- Give a straightforward answers
- Don’t offer information beyond what you have been asked
- Act confident, not defensive
- Know your role in the company
- Be respectful
- Comply with requests
- Follow company procedures

Learning Objectives:

- 1.1 - Describe the role of the FDA and other regulatory bodies in the manufacturing of medical devices.