Mock-Up FDA Inspections by an ex-FDA Investigator
ALP Sourcing has conducted mock-up FDA inspections for medical device manufacturers of in vitro diagnostics (IVD), implants, electronics, injection molding, sterile products, consumer products, and radiation devices, for the past 30 years. From management control to consumer complaint handling, from automatic warehouse distributions to raw material handling, we have experience and knowledge in conducting mock FDA audits.
Many consultants offer mock-up FDA inspections, and we are fully aware of the difficult decision that you will have to make in selecting the most qualified auditor for your products. ALP Sourcing strongly recommends hiring an auditor with background knowledge about your products. For example, if you are an in vitro diagnostics manufacturer, then you want to hire someone who has inspected one of the largest and most complex in vitro diagnostic manufacturers in the capacity of an FDA auditor, for either mock-up FDA inspections or actual FDA audits. For example, our consultants have experience with inspecting one of the largest in vitro diagnostic manufacturers in the world in the capacity of an FDA auditor for mock FDA audits and as a medical device investigator from the US FDA’s Office of Regulatory Affairs.
Unlike other consulting firms, ALP Sourcing allows only ex-FDA investigators experienced with different types of medical devices to perform mock FDA audits. That way, we are not there simply to conduct mock-up FDA inspections but also to give the best recommendations for corrective and preventive actions (CAPA) based on our many years of experience with similar products.
In addition, ALP Sourcing’s auditors have traveled around the world to conduct mock FDA audits — for example, in Europe (i.e., Ireland, Germany, Italy, France, Denmark, Swiss, the UK, Finland, Sweden, Norway, Austria, Hungary, and Czech Republic), Asia (i.e., China, Taiwan, Japan, and South Korea), the Americas (i.e., the US and Canada), and Oceania (i.e., Australia and New Zealand).
If ALP Sourcing is not your choice, then conduct diligent research and interviews to find the most qualified auditor for such an enormous undertaking. Don’t settle for second best. Money should not be a major factor in hiring mock FDA auditors. Instead, qualifications and experience should be more important in deciding on an auditor.