Mock FDA Audit
Why bother getting a mock FDA audit? If you are a medical device or pharmaceutical drug company executive, you should consider having an FDA mock inspection. To assure that your quality and manufacturing facilities conduct their operations in compliance with the law. In addition, several conditions at your company might further encourage you to get an FDA mock inspection.
Why Mock FDA Audit
- Firstly, if your noncompliance is more than acceptable or if you have out-of-specification products but are unsure about how to correct those problems;
- Secondly, if your company implemented or underwent a significant change to your quality policy manual;
- Thirdly, if you have hired a new quality department head or quality personnel;
- Fourthly, if you have launched a new product but have never been inspected by the United States Food and Drug Administration (US FDA); or
- Finally, if you have an unusual number of consumer complaints, Medical Device Reporting (MDR) reportable events, or product market removal or correction incidents.
With 30 years of combined FDA and industry experience
We are in a much better position to conduct a mock FDA audit than consultants without such experience. Furthermore, we know both sides of the story, and we bring both sides to the table. After 4 or 5 days of onsite mock FDA inspection, our auditor can answer most, if not all, of your questions about your company and the state of its compliance with FDA laws and regulations. Our former FDA investigator can conduct any type of FDA mock inspections, including for QSRs, pre-market approval, post-market approval, in vitro diagnostics (IVD), design controls, sterilization validation, and production and process controls (P&PC). Moreover, we can use the Quality System Inspection Technique (QSIT) method and indicate corrective and preventive actions (CAPA).
Please don’t wait until a problem emerges because, at that time, it may be too late to correct. Mock FDA inspections are not quick fixes but part of long-term plans for compliance with the law. Whether you are located in Australia, Switzerland, Germany, France, Ireland, United Kingdom (UK), Denmark, Finland, Japan, South Korea, Italy, China, or anywhere else in the world, we will travel to your facility. Finally, on the last day of the mock FDA audit, we will discuss major to minor concerns with you, as well as offer suggestions for resolving each identified problem. Please find out how you can benefit from our FDA mock inspection.
ALP Sourcing 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, ALP Sourcing 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.