What to Expect:

The FDA is required to contact you in advance of an inspection, informing you as to the purpose, estimated duration, and number of FDA personnel expected to take part. On the day of inspection, the FDA investigator will attempt to locate the top management official at your site. They are required to show their credentials to that official, and they must present an FDA Notice of Inspection. At that point, the inspection authority will conduct a thorough inspection of your facility, accompanied by one or more of your employees. Then, within a reasonable period of time after the actual inspection, the FDA will send members of your top management an Inspectional Observations form notifying you of objectionable conditions relating to products or processes or other violations to the FD&C Act and related Acts.

Potential Outcomes:

The results of an FDA inspection can range from no required actions to a complete shutdown of your facility accompanied by administrative, civil or criminal actions levied against you. In many cases, the FDA will make recommendations on how to improve your operations such that they are in compliance with the FD&C Act.

How to Prepare: 5 Ways

Here are 5 ways your organization can prepare for your next FDA inspection.

1. Conduct regular internal FD&C Act compliance checks: Of course, the best way to prepare for an FDA inspection is to make sure that your facility is in compliance with FDA regulations. Every employee within your organization should be kept abreast of the standards that the products and processes for which they are responsible must meet in order to be FD&C Act-compliant. Furthermore, employees should be trained to remain calm, be courteous to FDA inspectors, and comply with their requests. At the same time, your employees should know their rights in terms of what they are required to say or show to the FDA inspector and (as well as what they are not).

2. Identify and attend to potential weak spots: It is smart to identify potential areas or processes in your facility that will attract FDA attention during an inspection. Ask yourself: Which of our processes pose the most potential for contamination of the food, drugs or other consumable materials we are processing? Which areas of your facility appear to be under-maintained, unclean or potentially faulty? While the FDA will attempt to thoroughly inspect your entire facility, it is likely that they will be most thorough in inspecting these potential problem areas.

3. Elect point persons to accompany inspectors: At least two or more persons who oversee each major process within your facility should be trained to accompany an FDA representative during the inspection. Teach these "point persons" how to treat and interact with the inspectors.

4. Create an operating manual: Your employees should at all times have access to manuals which indicate the actions and steps they should take in order to remain FDA-compliant, both throughout the normal course of business operations and upon an FDA inspection. Having such a manual will educate your team and encourage them to handle the inspection with confidence.

5. Conduct regular FDA compliance checks: Rather than wait for an FDA inspection to discover problems in your processes or environment, it is wise to conduct regular compliance checks throughout your facility. You may even choose to have one of your employees act as if they were an FDA inspector and then ask your point persons and other employees to proceed as if you were undergoing an actual FDA inspection. Such practice runs can be a great way to build confidence among your employees and potentially uncover flaws in your operating procedure for inspections.

Undergoing an FDA inspection is something to which most companies do not look forward, for it means committing additional resources and energy in advance. However, being prepared can not only help you pass the inspection with flying colors, but it can also help you regain your peace of mind in the meantime.

Source: FDA Investigations Operations Manual 2007