What should I expect during an inspection?
FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions.
Usually, the investigator will examine your production process, look at certain records and collect samples. At the conclusion of the inspection, the investigator will discuss with your firm's management any significant findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator’s judgment, indicate objectionable conditions, or practices. This list of "Inspectional Observations," also called an FDA Form 483, can be used by your firm's management as a guide for corrective action, since the FDA representative will not usually recommend specific corrective measures. Your firm can and should respond to the FDA-483 during the discussion with the investigator. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.
If you do not agree with the actions being taken by the FDA or if you have a question about the jurisdiction of the agency in a particular matter, you can contact the FDA's Office of the Ombudsman to seek a resolution.
FDA Office of the Ombudsman
10903 New Hampshire Avenue
WO 32, Room 4231
Rockville, MD 20903
E-mail: firstname.lastname@example.org (sending confidential information by electronic mail is not recommended)
See the FDA Center Small Business Contacts for the Ombudsman in the various FDA Centers. If FDA takes regulatory action against your firm, the Small Business Representatives are not available for guidance, since their activities are nonregulatory in nature. You should contact a district Compliance Officer for advice under those circumstances.