Preparing for the FDA

You are going about your regular day when you suddenly receive a call from security: “The FDA is here.” You immediately call your boss: “The FDA is here.” Are you ready? Is your boss ready? Is the plant ready? Have you prepared for a FDA visit? An inspection gone wrong can lead to the dreaded FDA warning letter. Some consequences are immeasurable (e.g., reputation damage), others are directly measurable (e.g., loss of business). What is a practical solution for this problem?

To get an “inside” perspective on preparing for an FDA inspection, I spoke with Robert Wilson, president of FDA Regulatory Guidance, retired FDA supervisory investigator, and fellow member of the Strategic Alliance of Food Experts (SAFE). Following are our insights.

Always determine the reason for a visit. If the FDA investigator does not issue a Notice of Inspection, the visit is not an inspection and you are not required to provide the same information. At an inspection, the investigator’s job is to gather data and document jurisdiction, interstate, violation and responsibility (JIVR).

1. When the investigator arrives, he/she will request to meet with the most responsible person on site. Credentials will be presented and a written Notice of Inspection (FDA 482) issued. The person accepting the FDA 482 should be authorized and knowledgeable.
2. Determine the reason for the inspection. Is it routine (e.g., post-market follow-up or sample collection); is it more serious, (e.g., a “for cause” inspection for a suspected problem or recall); or is it a compliance follow-up (one you do not want)?
3. When the investigator asks a question, make sure you fully understand it before answering; then stop talking when it is fully answered and wait for the next question. The investigator will ask broad open-ended questions, so limit fishing expeditions. It is acceptable to allow silence and not volunteer information. You should answer all questions directly, but “Yes.” “No” and “I’ll have to find the information for you” are acceptable responses. If conflicts arise, negotiate immediately as best you can.
4. A plant tour should begin from the most controlled (clean) area to the least controlled (dirty) area. Do not start at receiving just because the investigator requested to start at the beginning. It is acceptable to have an investigator wait for a short time until a qualified individual is present to address questions. Note: an investigator is required to verify your answers. If employees are to be interviewed, ensure that the investigator is aware that you cannot allow an interview that would disrupt production, a sensitive operation, or a safety concern. Negotiate a different time and location.
5. If samples are requested, determine the reason, what the analysis will be, and who is to receive the results. Duplicate samples should be taken under the investigator’s direct supervision, and retained. The investigator will issue an FDA 484 (receipt for samples). If copies of material container labels are requested, duplicate copies should be taken and retained.
6. If copies of documentation or records are requested, only documents specific to the request should be provided. You should have an Inspectional Guide prepared in advance that includes examples of allowable documents to be provided upon request. You can (and should) deny non-allowable documents that are requested, such as financial records. Using food judgment, mark applicable copies “Confidential” to aid FDA in assuring no propriety data is accidently released under the Freedom of Information Act. Provide the requested documents as soon as possble, and maintain a list, making note of any missing documents.
7. Photography inside a food plant is a sensitive issue. The FDA investigator has the authority to take photographs whenever he/she believes it is necessary to document JIVR, usually related to insanitary conditions contributing filth to the finish product or practices likely to render product injurious or otherwise violative. However, a food plant does not want “dirty laundry” to be aired on the news. So you should be prepared to explain, defend, and present your company’s policy regarding photography and other recording devices. If a photo becomes an issue, negotiate immediately. If a raw material label cannot be made without destroying that label, move the container to a “photo-safe area” such as a parking lot for that photograph. If the investigator takes photos, take and retain duplicate photos. Be alert to any backgrounds that may be harmful to your defense. FDA is waiting for the perfect case on photography refusal to take to court, all the way to the Supreme Court. The best solution is not to have any insanitary conditions contributing filth or injurious practices inside your plant.
8. The investigator must close the inspection with the most responsible person present, not all interested parties. Do not sign any affidavits from the investigator, and inform him/her you must consult with legal counsel. If serious deficiencies have been found during the inspection, an Inspectional Observations (FDA 483) listing deficiencies will be issued. By FDA Policy, the inspection is over when the inspector says it is over and leaves the parking lot.
9. If an FDA 483 is issued, a careful evaluation should be conducted. The listed items are considered to not be in compliance with cGMPs, possibly resulting in a product being adulterated. A formal response should be prepared in detail to address each listed item.

The FDA is coming. Are you ready? Do be truthful, be concise, answer all questions directly, shadow each investigator, negotiate, and make notes of questions and responses. Do not speculate, guess, argue, or sign affidavits. The FDA investigator has a job to do and so do you. Prepare a plan, follow procedure, and practice to prevent a pitiful performance.