USFDA Inspection Types

The FDA and States assisting the FDA under contract or cooperative agreements, in general, perform three types of inspections: surveillance, compliance follow up, and for-cause.

Surveillance inspections are conducted to assess a facility’s or farm’s compliance with a regulation or to focus on an emerging trend in food safety. Surveillance inspections fall into two categories, routine and targeted.

Routine inspections of facilities and farms are conducted to assess regulatory compliance. The FDA Food Safety Modernization Act mandates an inspection frequency of at least once every three years for domestic high-risk facilities and at least once every five years for non-high-risk facilities. In addition, the Food and Drug Omnibus Reform Act of 2022 mandated annual inspections of infant formula manufacturers in accordance with a risk-based approach. If necessary, inspections can be conducted more frequently. The FDA seeks to achieve comparable coverage of imported foods using an array of regulatory tools, including U.S. importer verification, field examination, sampling, and foreign inspections.

Targeted, also known as Directed, inspections are based on specific food safety risks. Criteria for conducting a targeted inspection may include information related to an outbreak, risk factors that may lead to contamination, food consumption patterns, regional impacts, food safety trends and history of compliance.

Compliance Follow-Up inspections serve to verify compliance and/or corrective actions in the wake of previous violative inspections, violative samples or following official agency action (e.g., a warning letter or enforcement action). Prior observations of non-compliance, such as insanitary conditions or documented past failure on the part of a facility or a farm to implement an effective food safety plan, as required, may give rise to a compliance follow-up inspection.

For-Cause inspections are a type of compliance follow-up conducted to evaluate a firm’s actions in response to a specific issue, such as an outbreak of foodborne illness, consumer complaint or a product recall. For-cause inspections are often expedited.Inspection Process

The FDA’s approach to inspections is risk-based and seeks to form a complete understanding of a facility’s or farm’s food safety system. This enables FDA investigators to focus on significant observations that may adversely affect public health, to, when appropriate, promote voluntary corrections and to “educate while we regulate.”How to Help an FDA Food-Safety Inspection Run Smoothly

The FDA’s inspection process is as follows:

When the investigators arrive to conduct an inspection, they introduce themselves, show their credentials and issue a Notice of Inspection (FDA Form 482, for domestic inspections only) to the owner, operator or agent in charge.

Typically, the investigators will then conduct a system-based inspection beginning with an interview during which they verify and/or gather administrative information, such as the legal name and size of the business and the number of employees. During this same interview – if the FDA previously observed conditions or practices of concern to public health – the investigators will ask about corrective actions taken, as warranted, since the prior inspection and will verify correction has been implemented. The investigators also will select products to cover and collect operational information, such as hours of operation and sanitation schedule.

The investigators next will typically conduct a walk-through of the establishment – from the receipt of ingredients or seed to the distribution of products – observing processes, manufacturing, procedures and employee practices. During the walk-through, the investigators also may review written procedures and records and may speak with employees to help determine to what extent processes and procedures are being implemented.

Following the walk-through, the investigators typically request additional records to review to help them examine specific areas of the operation. Throughout the inspection, practices are evaluated and documents are reviewed for compliance with applicable requirements.

At the conclusion of the inspection, the investigators will provide to the facility or farm management a written list of significant inspectional observations (known as an FDA-483 Inspection Observations and FDA-4056 Produce Farm Inspection Observations). The investigators also may discuss labeling deviations with management as well as any lesser observations they may have made during the walk-through. This close-out discussion is an opportunity for management to ask questions about the investigators’ observations, to speak to any corrective actions they may have made during the inspection and to address corrective actions they plan to take going forward.

The management of the facility or farm is requested to submit to the FDA or other regulatory authority a written response addressing corrective actions within 15 working days of the inspection’s close. The FDA highly recommends written responses to both written observations listed on the FDA-483 or FDA 4056 as well as verbal observations discussed at the close-out meeting, as the FDA considers the written response and corrective actions when determining whether regulatory action should be taken.

After the FDA closes the inspection, the agency reviews the information gathered to assess compliance and consider further action, if warranted. Once the inspection is closed, a copy of the report will be sent to the individual identified at the start of the inspection as the owner, operator, or agent in charge.