The Coordinates:
We would all like the questions to a test ahead of time.
But unfortunately, an FDA audit doesn’t work that way. The FDA inspects many facilities every year across the spectrum of product types. So how do they determine how to get through this mountainous list? Manufactures have to register with the FDA and provide a list of products that they make. Different products have different risks-an implantable is different from a toothbrush. Those products with a higher risk have a greater need for an inspection.
They will look at reportable records and recalls not only for severity but frequency as well. Consumers or healthcare providers complain directly to the agency as well. This will draw attention to you. The newness of a device will also contribute to putting you on the list.
See You Soon
Some firms will be pre-notified of a planned inspection but it isn’t a long period of time. International inspections will be notified several weeks before. For others, there is no warning. You answer the door and there they are.
The investigators will show their credentials and issue the 482 form. This defines what they intend to inspect. Typically, this should be received by upper management, the person responsible for the site.
Starting Point
After escorting the investigators to the front room, many manufactures start with an opening presentation. This gives an overview of the site as well as provides some time for the backroom set-up. The overview can contain basic items such as number of employees, square footage of the facility, products manufactured, etc.
The auditors will then explain where they would like to start. They may make some initial requests and then ask to go out on the floor while you pull those items. There isn’t a specific inspection checklist per se, of what they look for out on the floor. Some investigators like to start at the warehouse and see raw material or components come in and then follow it through the process. Others may ask to go directly to see the manufacturing line for a particular product. Keep in mind that they are looking at everything along the way, from the cleanliness of the floor to a missing ceiling tile. They will look at what you have hanging on the wall to what is in a garbage can.
Operators may be asked questions about their activities. They may start with, “Tell me what you are doing?” “What is the procedure for this?” The operator’s training records for the task they were performing are free game. The investigator needs to see that that operator was trained to that SOP. The investigators may go to the floor several times as the audit progresses to see a process or to ensure that a procedure is followed.
Follow the Directions
The key take away is that you have procedures that meet the regulations and that you follow those procedures. Are you doing what you said you would do?
Their line of questions may sometimes seem random, but they are following a logical path. Although there are common questions, there is no master checklist of questions they go through. Reading warning letters and 483s is a way of learning about issues other companies have had. This may provide some direction on areas that investigators are focusing on. But every audit and investigator is unique. They will pull a thread and see where it leads. You don’t want the sweater to completely unravel!