The U.S. Food & Drug Administration (FDA) has a significant responsibility to the public. The agency is charged with ensuring the safety of food, cosmetics and any products that involve radiation. The FDA must ensure not only the safety, but the effectiveness of drugs and medical devices. Mistakes have serious consequences.
For that reason, the agency needs to perform regular inspections of the manufacturers in these areas. If you work for or with one of these companies, you need to be aware of what happens in an FDA inspection and how to prepare.
An FDA inspection can be done for a variety of reasons. There are times it can be simply an information-gathering exercise to aid in the establishment of new regulations or to understand new technologies. The more common inspection reason, though, is to document any violations of regulations.
The easy way for a company to prepare for an FDA inspection is simply not to have any violations. Of course, honest mistakes can happen at any company. Just as important, there can be an honest misunderstanding regarding what an inspector sees and documents.
The first step in preparation is knowing the reason for the FDA inspection. There are 4 basic types:
- Pre-approval inspection: In this case, the company has a new product and is seeking FDA approval. The inspection will confirm there are appropriate facilities for manufacturing.
- Routine inspections: These are required by law and inspectors are not obligated to tell a company when they are going to show up. However, the inspector is required to announce their presence upon arrival. This means they can’t go undercover, but can still catch a company by surprise.
- For-cause inspections: These happen in response to events. Perhaps consumers or whistle-blowing employees have reported issues with the product. Or maybe there was something in the news about bad consequences from product usage.
- Compliance follow-up inspections: These happen if there were significant violations on the initial inspection and are done to make sure the company is now in compliance.
The best way for a firm to be ready for what happens in an FDA inspection is to always be ready. That is, the culture of compliance has to be instilled from the top down and from the moment new employees are on-boarded into the organization.
As a part of ensuring the firm’s procedures are sharp, management should appoint someone to serve as a representative to the FDA and authorize them to perform mock inspections and document any regulatory failings. Problems that are uncovered internally can be quickly fixed.
Then when it’s “game day,” so to speak, and the real thing happens, the representative should be the one who greets the FDA inspector, along with the boss. Offer to give the inspector a good overview of your organization and its processes first. This gives you an opportunity to demonstrate competence and showcase your quality control systems.
Make sure that thorough notes are taken on what is said during the initial meeting, the inspection itself and the follow-up meeting. Spend time with the inspector and review their findings. This allows you an opportunity to clear up any misunderstandings that have arisen during the inspection process.
Safety and compliance are the first priorities and those can be developed every day of the year. On inspection day, good processes are simply about making sure the FDA sees and understands the reality of your quality control systems.