ExportUSA offers a support service to prepare and be prepared for FDA inspections. Our consultants are also available to be on site during FDA inspections
During the inspection, having on site an expert in FDA inspection and control procedures is a great advantage because it avoids misunderstandings, speeds up the procedure and ensures that the most suitable answers are provided to FDA inspectors. The importance of preparation for inspections
Be ready for FDA inspections: ExportUSA's technical staff has more than ten years of experience in managing FDA inspections
We have a solid technical background in food safety certifications and are familiar with the legislation that applies to food preparations intended for import into the United States of America
FDA consultancy for assistance and coaching on site during FDA inspections:
- Presence on site during all the days in which the inspectors conduct the inspection;
- Support to Management during the interview that concludes the inspection;
- Support in responding to the report letter provided by the FDA in the days following the inspection;
- Support in the design and implementation of corrective actions [if any] requested by the FDA in the report letter
- Before the arrival of the inspectors, FDA inspection preparation service consisting of a day on site spent with Production, Marketing, Administrative and Management personnel.
In addition to handling the FDA inspection, ExportUSA's FDA consulting services can also extend to your company's compliance with the new food safety regulations in force in the United States.
FDA inspections must be faced with peace of mind
For companies that have long been active in exporting specialty foods to the United States, they are an event to be taken into account, especially now that the FDA has increased its focus on food safety issues, culminating in the entry into force of all FSMA regulations. which, for the first time, also involves US food importers.
Notice of inspection by the FDA
Importance of preparing the FDA inspection in advance
FDA inspections never come on a moment's notice. If anything, for practical reasons: the inspectors arrive from the US and a situation where the company is closed or the food safety managers are not available would be rather embarrassing.
For this reason, the FDA always announces the dates of its inspections, typically by emailing the company and the selected FDA agent. The email announces the inspection and proposes dates, asking which ones are acceptable to the company. There is no problem proposing different dates: the FDA inspectors will accommodate the request.
All communications with the FDA can safely be conducted by email. The email announcing the inspection will include name, title and telephone number of the FDA manager who is in charge of coordinating the inspectors' activities.
To arrange the inspection, the FDA will also ask for basic information, such as name of the nearest airport, name of two or three hotels that are close to the company to be inspected, and similar information. It goes without saying that maximum cooperation by the company is a must.
In these early stages of contact with the FDA, it is important to stick to the sound military rule of "question, answer"; do not go beyond what you are asked, and, avoid making invitations to dinner and other similar offers.
You will see that FDA inspectors are warm, honest, fair, and impartial people ... decent people who do their job and, in all honesty, try to help to make sure that companies are up to standard in order to continue exporting their food products to the US. They do not make inspections to "get you".
For this reason, truthfully, there is nothing to worry about. Perhaps in the days preceding the inspection, prepare the visit by beginning to inform everyone in the company that the FDA inspectors are arriving, instruct the reception on what to do when the FDA inspectors show up and, of course, always have a person who speaks good English in attendance, as well as somebody who is well versed in the company's manufacturing procedures and food safety practices.
How FDA inspections are conducted and what to expect when FDA inspectors arrive at the company
The FDA may conduct an inspection of your company for a variety of reasons: scheduled routine inspection, or in response to a reported problem.
In the vast majority of cases, as we said, the FDA sends an email to the company at least a couple of months in advance of the inspectors' arrival date.
On that occasion, the company can ask for a postponement of the inspection. Normally, the FDA sends two inspectors and the inspection lasts an average of three days [except in special cases].
Upon arrival, the FDA inspector will submit his credentials along with the "Food Facility Inspection Notice" form (FDA Form 482). It would be preferable for the FDA inspectors to be accompanied throughout their stay by an employee experienced in food production, such as the Director of the Production Facility or a person designated at the time the inspection was set up.
It is in the company's interest to become fully familiar with the FDA inspection procedures and, if you have any doubts or uncertainties regarding the procedures, never hesitate to ask questions
Usually, the inspector examines the production process, checks production and warehouse notes, and may also collect samples of the food products stored or produced on site
At the end of the inspection, the inspector will discuss with Management all the findings and any significant critical issues that have emerged.
The FDA inspection then ends with a written report containing the inspector's list of observations ["Inspectional Observations"], also called FDA Form 483. These observations can be used by the company's Management as a guide for corrective actions to be taken, since the FDA inspector normally does not recommend specific corrective measures.
The company must address the observations listed on the FDA-483 form during discussions with the inspector. All corrective actions that can be implemented in the short term are highly appreciated by the FDA as an indication of the willingness to comply with FDA regulations for importing food into the United States.
Once the inspection is complete, a letter will be sent by the FDA documenting the inspection results. Any regulatory deficiencies are listed on FDA Form 483 along with the deadlines by which corrective actions must be implemented. Finally, the FDA letter always closes with instructions on how to address the observations made by the inspector.