The first rule in an FDA inspection is to be prepared before you get that knock on the door from an inspector.

Do you have a compliance officer?

Do you have a compliance program?

Is your hard copy FDA paperwork in order and available?

What do you do if an Inspector is at a customer location?

Can you refuse access to your operations to a FDA inspector?

What does an EIR mean to your company?

What does a 483 report mean to your company?

Are your form 2579 reports completed and accurate?

Do you know your requirements for filing out a form 2579?

Do you have the safety and reporting systems in place?

What do you do if you fail an FDA inspection?

How do you survive an FDA inspection?

These are just some of the questions that any person responsible for a Hospital In House service program, Asset Management, ISO or Broker operations must be prepared to answer if you are going to survive an FDA inspection.

What can the FDA do to your operations?

Fines, injunctions, seizure, repeat inspections and other enforcement acts as the FDA and States deems necessary to protect the public health, safety and welfare.

In today’s world not being prepared or not knowing your responsibility is not an acceptable policy.

For in House operations, know, in writing, that the Manufacturers (OEM’s), Asset Managers, ISO or Brokers you do business with are in compliance with FDA laws.

For OEMs, Asset Managers, ISO’s or Brokers get into compliance and start obeying the laws.

What does your organization do to prepare?