Preparing for an FDA Audit

Preparing for an FDA Audit

Helen Timothy
January 12, 2021

eBook: Are You Ready for an Audit?

Download eBook

eBook: “Are You Ready for an Audit?”

Supply chain threats are part of doing business in the food, supplement, and CPG industries. Yet many companies still rely on email and three-ring binders to conduct audits. Download our eBook to discover how to automate your audit program.

Download eBook

As a result of the Food and Drug Administration's (FDA) Food Safety Modernization Act (FSMA), food inspections are on the rise.

It's essential to audit-proof your organization, so you're ready for any audit at any time. Here are a few tips to help you get started:

Know the Latest in Standards and Rules

Think of audits as a test in which you already have all the answers. You know the standards and guidelines by which your facility must adhere; it's just a matter of making sure you are up-to-date with any changes. Make sure to review these standards regularly. Make sure to consistently check your company's chosen scheme (BRCGS, SQF, FSSC 2200, etc.) frequently. TraceGains hosts regular webinars to cover updates and new rules - take a look at on-demand and upcoming webinars here.

Conduct Internal Audits Frequently

To make sure you are always prepared for an unannounced audit, make sure you conduct one yourself regularly. To do this, have a checklist handy and schedule out some time for a daylong walk-through. If possible, try to look at your operations from an outside perspective to really see if there are any concerns or issues you have to address.

Manage Your Documents Efficiently

The one thing an auditor will surely request from you will be documents, many, many documents. Make sure your Certificates of Analysis (COAs), invoices, product labels, and any other supplier documentation are organized and ready to produce at any time. 

Automation can help by digitizing operations and extracting intelligence and critical data. Not only will this save you time, but it can also help point the way to new opportunities and even help to shed light on gaps in your supply chain. Document management and recordkeeping are significant components to ensuring you are audit ready 365 days a year. 

Read our eBook, "Are You Ready for an Audit," to gain more useful tips and learn how automation can transform your team. Download the eBook here