An unexpected visit from an inspector at your facility can leave you feeling vulnerable and unsure of what's in store. And what if you're not there when the inspectors arrive? Is your entire staff on the same page, and clear on what to expect and how to proceed?
We've heard from our members that this can be one of the most anxiety-inducing occurrences for you and your team, temporarily disrupting operations and often leading to confusion. To help you prepare for an FDA inspection, ensure you know the proper steps an inspector should follow, understand your rights and requirements, and make the process run more smoothly for you and the inspectors, ACS reached out to FDA to request a concise guide to inspections.
This three-page guide, available exclusively to ACS members, covers the steps you can expect during an inspection, as well as when your product is collected for sampling. It includes:
- What credentials an FDA representative should present
- Information on inspectors' dress, and why uniforms may be worn
- Reasons samples might be collected
- Size of samples you can expect to have taken
- Environmental swabbing protocols
- How to request payment for product taken for sampling
- Sample analysis, testing, and timing of results
- Sharing of results with state and local authorities
Access the full document now by logging in to the Member Resources section of our website.