Due to a recent push by the FDA for more foreign food inspections, it is important that all foreign facilities are up to par. No matter what capacity they contribute in (packing, processing, or holding food) these facilities are subject to inspection by the FDA.

It can be difficult to navigate new requirements for foreign facilities under FSMA, but here is an overview of what your company should know when it comes to the inspection process (developed directly from the FDA website).

The focus of the FDA’s efforts should be the focus of your company as well, targeting high-risk foreign food entities. Tiering risk based on the history of compliance, manufacturing/processing practices, and the type of food involved is the first step to identifying where improvement is necessary.

Eliminating or decreasing the risk factors through proper activities will shift the attention of the FDA elsewhere.

Where To Look When The FDA Arrives

If the FDA does arrive onsite, however, there are a few places they will be looking. Overall compliance outlined in the Federal Food, Drug, and Cosmetic Act and Title 21 of the U.S. Code of Federal Regulations (CFR) is the guideline for inspection.

For each individual food this will look different.

Canned foods, for example, fall under low-acid canned or acidified food regulations (21 CFR Parts 113 and 114) while dietary supplements will have to align with good manufacturing practices for dietary supplements (21 CFR Part 11).

Determining the major components that the the FDA will be concerned with for your foreign suppliers will appropriately direct your efforts. Keep in mind that one product might fit into multiple categories for compliance.

An inspection usually takes 1 to 3 days within a 2 to 3 week trip of the FDA inspection team to a particular country. During each trip, inspections generally are held at 4 or more facilities. Sometimes one country is visited several times a year.

A notice of inspection will be sent to facilities prior to the arrival of the FDA. This should be immediately acknowledged with permission for the FDA to carry out the inspection. If permission is not granted to the FDA, it has the right to refuse entry into the United States among other action.

Any corrective action deemed necessary through the inspection should be attended to as soon as possible. If it takes place during the course of an inspection, it can be approved by the investigators already on site. In this way, reinspection fees may be avoided.

The facilities’ risk profile will also be constructed upon the completion of inspection, which will impact the level of involvement the FDA will subsequently adhere to. This is detailed on the FDA’s page on Importing Products into the United States.

With adequate systems in place, an inspection by the FDA shouldn’t be a source of nervousness for your foreign facilities. Although this can be hard to juggle on a large scale, it is possible.

About the Author

Michael de la Torre is the CEO of Govzilla.

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