The business stakes and risks that flow from an FDA inspection have never been more significant. Even though the FDA has generally been more proactive and helpful in its regulatory approach, the flip side of this coin is that they expect companies to follow the regulations and expectations, and be ready – all the time – to answer FDA investigator questions.

Failing to meet FDA investigator expectations and withering questions during an inspection can result in costly regulatory actions, from FDA 483 observations to warning letters, recalls, consent decrees, or worse! These devastating potential impacts are why obtaining thorough, well-structured inspection preparation is essential to your company’s business.

Compliance Architects’ inspection readiness services not only cover the technical and procedural aspects of inspection readiness but also help employees build confidence through real-world scenarios and coaching. Our services focus on optimizing inspection mobilization activities and readiness, enabling your team to act quickly when the call comes and to handle any FDA inspection with the speed, knowledge, and assurance necessary.

At Compliance Architects, we bring decades of hands-on FDA and industry experience to conduct mock inspections with rigor and precision. Generally, we recommend mock inspections be performed by our best-in-class ex-FDA Investigators. These experts have served in FDA Investigator roles across regulated industries and understand exactly what FDA Investigators look for during inspections. This allows us to deliver realistic and impactful mock inspection experiences.