FDA Mock Audits
If you need FDA mock audits, then you have come to the right place. Take a few minutes to read our website’s homepage. We are a group of former FDA agents who help medical device and pharmaceutical manufacturers such as your organization with FDA mock audits. According the FDA’s compiled list of inspection observations for medical device manufacturers, the top 10 observations made over the course of a year were that:
1. CAPA procedures had not been adequately established;
2. Complaint handling procedures had not been adequately established;
3. Purchasing control procedures had not been adequately established;
4. A process whose results can be fully verified had not been adequately validated;
5. MDR procedures had not been developed, maintained, or implemented;
6. Nonconformance procedures had not been adequately established;
7. Procedures for quality audits had not been adequately established;
8. CAPA activities and/or results have not been adequately documented;
9. Design Change procedures have not been adequately established; and
10. Training procedures have not been adequately established.
Just as most other manufacturers, your company has probably established all of those procedures, but are they “adequately” established? If you are unsure, then you need to schedule mock FDA audits to be performed by someone who has performed such audits for the last 30 years and can find gaps in your quality systems.
Although regulations concerning Medical Device Reporting (MDR) are not as complex, they are surprisingly misunderstood by many quality and regulatory personnel. Our auditors are experts when it comes to MDR regulation, for we have enforced them as FDA agents since they became effective for user facilities and device manufacturers in 1996 with the new Medical Device Reporting regulation. Remember, according to the SMDA, “All manufacturers of finished medical devices and components which are ready for use, including foreign manufacturers, are now subject to the requirements of the MDR regulation, despite registration status.” Hire the right auditor for your next FDA mock audits.