FDA Inspection Checklist
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A significant part of ensuring a successful FDA inspection should be completed well ahead of the arrival of the FDA investigators. Every company should start working immediately to ensure they have accomplished several crucial tasks.
Firstly, identify a suitable meeting space within your facility for hosting the FDA investigators when they arrive. This could be a conference room or an empty office with enough desk space to review large amounts of records. However, ensure that the space is free of any records—whether in binders, boxes, or on computers—that the investigators could access unsupervised.
Assign a primary and secondary Designated Individual (DI) for each facility to act as the liaison with the FDA investigators once they arrive. DIs should arrange their vacation schedules to guarantee that at least one DI will always be available when FDA visits.
Ensure that the primary DI has undergone FDA’s Preventive Control Qualified Individual (PCQI) Training. Although the training isn't mandated by FDA regulations to become a Qualified Individual, investigators typically expect at least one facility employee to have completed the training.
Finalize your written food safety systems and ensure that the primary and secondary DIs are familiar with each element of these plans. Depending on the size of the business and the type of products, this might include Good Manufacturing Practices (GMPs), Sanitation Programs, Preventive Control Plans, Recall Plans, Environmental Monitoring Programs, Foreign Supplier Verification Plans, Sanitary Transportation Plans, Food Defense Plans, and Produce Safety Plans.
Organize and maintain supporting records for each program in a way that allows the DI to quickly retrieve the past three months of records for FDA review. While FDA requires most records to be kept for at least two years, investigators typically only ask to review records from the previous three months.
Document corrective actions properly. Whenever there’s a deviation, document all corrective actions accurately. Each corrective action should identify the root cause of the deviation, actions taken to prevent recurrence, and, if product safety isn't affected, a written conclusion (supported by factual and scientific data) stating that the deviation “does not create an immediate food safety issue.â€
Equip your sanitation staff with high-power flashlights similar to those the FDA investigators will use. This ensures that your employees can see and clean what the FDA would observe when it arrives.
Verify that your allergen controls are adequate. Accurate ingredient labels and measures to avoid cross-contact are essential.
If your company processes ready-to-eat foods exposed to the environment before packaging, ensure you have an environmental monitoring program in place before FDA arrives. Conduct more environmental sampling. Since FDA will collect between 100 and 200 microbiological samples from your facility, it’s vital to know what they’ll find beforehand. Conduct your own swabbing to identify and correct hidden problems.
Develop a policy for retaining microbiological samples. If your lab retains isolates or testing materials indefinitely, establish a policy requiring the lab to discard all testing material within 24 hours after testing, as long as the records of the final results are maintained.
Create a policy for handling companion samples. When FDA collects samples, some companies opt to collect companion samples simultaneously. If you choose to do this, ensure there’s a policy governing how these samples will be handled, tested, and/or discarded.
Consider developing a “No Photographs†policy. In many cases, FDA investigators will want to take photos while inspecting the processing environment. If you have a corporate policy preventing visitors from taking photos, you might use this policy to prevent FDA from photographing your facility.
Establish a “Do Not Sign†policy. Sometimes, FDA investigators will ask a company representative to sign a statement or affidavit. You're not legally obligated to do so. Develop a policy stating that you will neither sign nor acknowledge any written statements presented by FDA investigators.
Identify an appropriate FDA lawyer who can be notified and remain “on call†once an inspection begins. This person can help quickly answer any complex regulatory or investigator-related questions that arise.
Conduct a mock FDA inspection. One of the best ways to prepare for an FDA visit is to simulate an inspection. Consultants and/or lawyers can visit your facility and play the role of FDA investigators. They can review your programs to identify potential regulatory shortcomings and help implement strategies to strengthen your programs and reduce regulatory risks.
When the day arrives, the FDA investigators will show up unannounced. They'll present their credentials and request an entrance meeting. During this meeting, the investigators will outline their inspection plan, anticipated duration, and specific tasks. These tasks typically include a facility inspection, a records review, and a swab-a-thon where investigators collect around 100 to 200 microbiological samples.
The entire inspection process usually takes a few days and can extend to weeks. Once the inspection starts, use the following checklist to guide you through the process:
Attempt to negotiate the areas being sampled. During the entrance meeting, the investigators will usually disclose the types of ingredients, products, and environmental areas they intend to sample. Try negotiating with the agency to limit the amount, type, or focus of the sampling to minimize the impact of any positive results.
Carefully document the areas sampled by FDA. While the investigators are sampling, meticulously document the exact locations from which samples are collected. Also, categorize these areas as Zone 1, Zone 2, Zone 3, or Zone 4. This information will be crucial if any samples test positive to determine the best response.
Consider whether to collect companion samples. Sometimes, companion samples test positive even when FDA samples test negative. While companion sampling increases the chance of finding positives, consult legal counsel to decide if it’s advisable in your situation.
Hold any product FDA samples. If FDA collects finished product samples to test for pathogens, hold any products from the same lot or batch or any products made using the same ingredients until the results come back. If any results are positive, and the product has been held, a recall won’t be necessary.
Aggressively clean and sanitize all areas sampled by FDA. As soon as possible after FDA completes its sampling, thoroughly clean and sanitize each area. This shows that any contamination present at the time of sampling has been eliminated and couldn’t have affected subsequent production.
Correct all FDA observations immediately. During the inspection, the investigators will likely share their findings with the DI. Where possible, address and resolve any critical observations promptly. This demonstrates the company’s commitment to quick resolution and may lead the investigators to omit these observations from the final FDA Form 483.
Understand what records FDA is permitted to review. FDA has broad powers to access records. Generally, they can review written food safety programs and related records. However, they cannot review or copy recipes, financial data, pricing data, personal data (except to confirm employee training is appropriate), research data, or sales data (except for shipment information).
Protect the confidentiality of any copied records. If FDA requests copies of confidential records, mark them with the following statement: THIS DOCUMENT AND THE INFORMATION CONTAINED HEREIN CONSTITUTES TRADE SECRET, CONFIDENTIAL AND PROPRIETARY COMMERCIAL INFORMATION PURSUANT TO 5 U.S.C. 552(b)(4), AND SHALL BE STRICTLY PROTECTED AS SUCH FROM ANY DISSEMINATION AND/OR DISCLOSURE.
Ensure that FDA investigators remain accompanied. This way, the DI can observe and document the actions of the investigators and respond immediately to any concerns. Having a company employee present at all times discourages the investigators from developing or discussing additional unplanned inspection strategies.
Avoid signing any statements or affidavits. At the end of the inspection, the investigators may ask you or your employees to sign a statement or affidavit. Do not sign or acknowledge any documents, as you’re not legally obligated to do so. If such a request is made, consult your FDA lawyer immediately.
Once the FDA investigators finish their tasks, they will conduct an exit interview and share their findings, observations, and conclusions. In most cases, where violations are identified, the investigators will issue an FDA Form 483 detailing the specific violations observed.
If FDA issues a Form 483, prepare a written response. During the exit interview, the investigators will likely present their observations, findings, and conclusions. Regulatory or food safety violations will usually be documented in an FDA Form 483. Though a response isn’t legally required, companies are generally expected to provide a written response within 15 business days. An adequate response can prevent further regulatory action.
Support your written response with documentation. When FDA issues a Form 483 or a Warning Letter, ensure your response is adequately supported with documentation. For example, simply stating that you corrected a problem by “conducting additional employee training†won’t suffice. Attach a training log or another document proving the training occurred.
If FDA suggests a recall, consult your FDA counsel. Sometimes, the investigators will observe conditions they believe warrant a recall. Deciding whether to announce a recall and the scope depends on the facts and data. Consult an experienced FDA compliance attorney before making any decisions.
Though countless factors will influence your next FDA inspection, the information provided here is meant to offer some tools to handle common scenarios. I hope these checklists prove useful as you prepare for and manage your next FDA inspection.
About the Author: Shawn Stevens is a food safety consultant and lawyer, and the founding member of Food Industry Counsel LLC, the only law firm in the world that represents the food industry exclusively. He helps clients across the globe comply with FDA and USDA food safety regulations, manage recalls, and defend against foodborne illness claims. Learn more about his legal and consulting practice at: www.foodindustrycounsel.com.
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