AP Consulting and our consultants do not claim that our mock FDA inspections will guarantee that you will not receive a warning letter from the US Food and Drug Administration (FDA) or Form FDA-483, Inspectional Observations. As a consulting firm, we are not responsible for any outcomes or actions as a result of our consultations or mock FDA inspections. In addition, AP Consulting does not represent or imply that we represent the US FDA or US FDA investigators in any way and does not claim to know everything or have answers to all of your questions. We will do our best to answer your questions based on our years of experience.
Please note that this website does not represent the FDA or its position. The FDA updates its regulatory policies from time to time. Therefore, this website may not be accurate. Please check the FDA website for up-to-date policies and guidelines. In addition, this article is solely based on a limited experience working as a field and center Compliance Officer. As such, we do not claim that we can remedy your current conditions or situations with the FDA. We are not here to fix the problem, but to act as a consultancy and for advisement.