New Developments for FDA Inspections

Significant change for FDA inspections of foreign manufacturers: Starting May 6, 2025, FDA inspections will be conducted without prior notice.

The U.S. Food and Drug Administration (FDA) announced today, May 6, 2025, its intention to conduct surprise inspections without prior notice at foreign food production facilities, as well as for cosmetics, dietary supplements, and medical devices.

This initiative is based on the Foreign Unannounced Inspection pilot program by the Office of Inspection and Investigations active in India and China, aiming to ensure foreign food production facilities are held to the same standards as American producers.

For too long, foreign companies have benefited from a double standard: they were given ample notice before inspections, while American producers are subject to rigorous checks without any notice. This system will end today. This is a key step in the FDA's strategy to bring foreign inspections up to an appropriate level, stated Martin A. Makary, M.D., M.P.H., Commissioner FDA

Each year, the FDA conducts approximately 12,000 inspections of American food producers and 3,000 inspections of foreign food producers in over 90 countries. While U.S. producers undergo frequent and unannounced checks, foreign companies receive weeks of notice, undermining the credibility of the FDA's oversight efforts. Despite the notice, FDA inspections often reveal serious deficiencies, sometimes more frequently than in America.

Only in specific programs and under particular circumstances are FDA inspections of American producers announced in advance, to ensure the availability of essential documents or personnel. However, in these cases, companies are not allowed to negotiate the date and time of the inspection. Foreign production companies should not enjoy such privileges.

The FDA will be authorized to take sanctioning measures against any company that delays, obstructs, or limits an FDA inspection or denies access to the facility during an unannounced inspection.
 

FDA Consulting for Assistance and Support in Companies During FDA Inspections

• Support for company management during the meeting that concludes the inspection;
• Assistance in responding to the observation letter that will arrive from the FDA in the days following the inspection;
• Consulting for the design and implementation of corrective actions required by the FDA in the observation letter [if any]
• In addition to managing the FDA inspection, ExportUSA's FDA consulting also extends to bringing your company into compliance with the new FSMA food safety regulations in force in the United States.

Update of March 15, 2021

FDA Inspections Should Be Approached Calmly

For companies that have been active for some time in exporting food specialties to the United States, they are an event to be accounted for, especially now that the FDA has increased its focus on food safety issues, culminating with the full implementation of all FSMA regulations, which, for the first time, also involve American importers of food products.
 

FDA Inspection Notice and the Importance of Preparing for FDA Inspections in Advance

In light of the changes in the FDA inspection procedure reported above, the content of this chapter is to be considered outdated.

FDA inspections never happen unexpectedly. If for no other reason than practical issues: inspectors come from America, and finding themselves in a situation where perhaps the company is closed or the food safety officers are absent would be quite embarrassing. In the vast majority of cases, as we mentioned, 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 has the opportunity to request a postponement of the date. Normally, the FDA inspectors who show up at the company are two, and an inspection lasts on average three days [unless otherwise specified] 

Therefore, the FDA always announces inspection dates, typically by sending an email to the company and the FDA agent listed in the company's registration with the FDA. The email announces the inspection and proposes dates asking if they are suitable for the company. There is no problem proposing different dates: the FDA inspectors will accommodate the request. To organize the inspection, the FDA will also ask for basic information such as the name of the nearest airport, the names of two or three hotels that are close to the company being inspected, and similar details. It is advisable to be fully cooperative in this regard.

All communications with the FDA can easily occur via email. The email announcing the inspection will include the name, title, and phone number of the FDA manager coordinating the inspectors' activities.
 

How FDA Inspections Are Conducted and What to Expect When FDA Inspectors Arrive at Your Company

The FDA may conduct an inspection of your company for a variety of reasons: a scheduled routine inspection or in response to a reported issue.

In these initial interactions with the FDA, adhere to the basic military rule of "question, answer"—do not go beyond what is asked, and avoid dinner invitations and the like.

You'll find that FDA inspectors are cordial, honest, fair, and impartial... decent people doing their job and sincerely trying to help ensure companies comply so they can continue exporting their food products to America. They are not there to "catch you out."

So, really, stay calm. Perhaps in the days leading up to the inspection, prepare for the visit by informing everyone at the company that FDA inspectors are coming, instructing the reception on what to do when the FDA inspectors arrive, and naturally having someone available who speaks good English and understands your company's production procedures and food safety practices.

Upon arrival, the FDA inspector will present their credentials along with the form "Notice of Inspection of a Food Facility" (FDA Form 482). It would be preferable if someone experienced in food production, such as the production plant manager or, preferably, someone designated at the time of organizing the inspection, accompanies the FDA inspectors throughout their time at the company.

It is in the company's interest to fully familiarize itself with FDA inspection procedures, and if you have any doubts or uncertainties regarding the procedures, do not hesitate to ask questions. Usually, the inspector examines the production process, reviews production and inventory notes, and may also collect samples of food products stored or produced at the company.
 

How the FDA Inspection Concludes

At the conclusion of the inspection, the inspector will discuss with the company's management all the findings and any significant issues identified.

The FDA inspection then concludes with a written report that contains the inspector's list of observations ["Inspectional Observations,"], also known as FDA Form 483.
These observations can be used by the company's management as a guide for corrective actions to be taken, as the FDA inspector typically does not recommend specific corrective measures.

The company must respond to the observations contained in FDA Form 483 during the discussion with the inspector. Any corrective actions that can be implemented on the spot 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 completed, a letter from the FDA documenting the inspection results will arrive. If regulatory deficiencies are found, they will be listed in FDA Form 483 along with the timeframes for implementing corrective actions. The FDA letter always concludes with instructions on how to respond to the inspector's observations.