This fact sheet offers simple tips to help an FDA food-safety inspection run as efficiently as possible for both the agency and your firm. It also features information on the FDA’s inspectional process to help you know what to expect.
Suggestions for Industry
- Be knowledgeable about the FDA requirements that apply to your facility or farm.
- Ensure that employees are educated, trained, and experienced in food hygiene and food safety consistent with their assigned duties.
- Familiarize yourself with the FDA’s Technical Assistance Network (TAN), which provides frequently asked questions and answers.
- Explain safety, security, and visitor procedures at the beginning of the inspection so that FDA investigators are aware of and understand your firm’s procedures.
- Have personnel available to answer questions and provide documents for review.
- Kindly ask whatever questions you may have and engage in open dialog with the investigators.
- If possible, prior to the close of the inspection, take voluntary corrective actions in response to observations made during the inspection. This will allow the investigators to verify corrective actions taken before the close of the inspection.
- Have required records organized and available for review in a timely manner.
- If the investigators collect samples during the inspection, let them know whether your firm will voluntarily hold product pending receipt of the test results. The investigators will seek to ensure prompt notification of laboratory results.
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.” 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.
- Additional information on food-safety inspections is available in the FDA’s Investigations Operations Manual (Chapter 5).
Some FDA investigators may be in uniform when they arrive to conduct an inspection. These investigators are active duty officers within the Commissioned Corps of the U.S. Public Health Service (USPHS) – professionals dedicated to protecting and promoting public health. They are required to be in uniform when on duty. Though their uniform is similar to military dress, these health professionals are not members of the armed forces and work only in the interest of health promotion and disease prevention. USPHS is a component of the Department of Health and Human Services and is directed by the U.S. Surgeon General.