Mock PAI Audits/ Regulatory Inspection Readiness

Microrite’s team of former FDA inspectors and technical experts perform mock PAI audits via a unique approach. This congruent team evaluates client readiness for regulatory inspection. They provide unique insight into how inspections are performed and what inspectors look for. A mock PAI audit by Microrite also becomes a learning experience for the client in order to understand gaps and correct deficiencies prior to pre-approval inspection. While our audit goal is to get you ready for regulatory inspection, we also leave you with the framework to optimize your operations for long term compliance.

It is essential to be prepared for an inspection, whether they are a planned visit or an unexpected drop in. A prepared team and comprehensive documentation is always the best proactive strategy in order to make inspections as smooth as possible. While the quality team is often the initial team to interface with inspectors, all other departments do get questioned and scrutinized.  It is crucial that all departments have a thorough understanding of their processes and systems and can face the inspectors with confidence.