In order to ensure that businesses are following safety rules and regulations set by the U.S. Food and Drug Administration (FDA), the agency will periodically perform on-site inspections of those businesses. Sometimes the inspections occur without notice. Because of this it is important to ensure that you are ready to pass an inspection at anytime. Here are some tips for handling an inspection.
Be Familiar With What Happens During an Inspection
Although what the inspector is looking for can vary based on the nature of the business, there are some basics to know for the inspection. For instance, the inspector will review your training documentation for employees and ensure that they are in compliance with federal standards.
The inspector can also collect samples of the product being manufactured. He or she can also talk to the employees regarding the manufacturing of the products and check for understanding of the safety procedures that are in place. He or she can also ask to see any records that have to do with the manufactured product.
It is important to note that there are some areas of your business that the inspector is not entitled to certain records. For instance, the inspector cannot look at your financial or research records. He or she also cannot ask to see any personnel data other than training records.
Refrain From Arguing With the Inspector
Even if you do not agree with the criticisms or observations of the inspector, it is important that you refrain from arguing with him or her. The inspector's job is to remain objective while inspecting your business. Any criticisms that he or she has are not personal attacks on you or your employees.
If you do disagree with an observation made by the inspector or feel that he or she is being unreasonable, you can file a complaint with his or her supervisor. Your FDA attorney can help you dispute the inspection results.
Regardless of whether or not you agree with the inspection, keep notes. Your notes can be useful to your attorney if you plan to dispute the findings. The notes can also be useful in helping you and your employees pinpoint what did and did not work in the eyes of the inspector. You can use this to make adjustments for future inspections.
Consult with your FDA attorney, like those at Mohajerian A Professional Law Corporation or a similar firm, to learn of other ways you can pass an inspection. He or she can also help keep you informed of any regulations changes that can have an impact on your business.