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How to Always Be Prepared for FDA Audits

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It doesn't matter which industry you work in: eventually an FDA inspector will show up, clipboard and their checklists in tow. Depending on how well you’re prepared, an FDA inspection can either be no big deal… or a nightmare.

Luckily, preparing for an FDA inspection is surprisingly easy. If you get ready now, you can save yourself a lot of time in the future. Here are four easy-to-implement general tips that will help your business prepare for future FDA inspections. If you can follow these tips, you’ll get through your next inspection as painlessly as possible.

Keep records organized and accessible.

FDA inspections can take a while. We’re talking days, weeks, and even months in some extreme cases. You can help speed things along by making sure you keep all the important documents and records in a prepared binder. This will make it easy for your inspector to access the information they need in a singular place.

When you’re preparing your binder, include:

  • procedures related to handling complaints
  • a high-level overview of your system
  • organizational charts
  • training records
  • inventory lists
  • employee licensing and certifications
  • and anything else you think is relevant

Keep things properly labeled.

With any inspection, there's a likelihood that the investigator will need or want to look at things you didn't already have prepared. These could be quality-related documents and records, clinical program notes, or several other documents.Make sure all your paperwork is properly labeled. This is especially relevant for items that could relate to regulatory compliance, like product descriptions and marketing materials.

Prepare any product complaints or CAPAs that have been submitted since your previous inspection.

All of our tips involve, to a degree, making sure the info you need is organized and accessible. This will really help the inspection proceed as quickly and easily as possible. Inspectors commonly ask for are product complaints and CAPAs (Corrective and Preventive Action reports). Sharing this info may make you uncomfortable, but it’s always more important to be clear than avoidant.

Run mock inspections.

According to the FDA, there are four main steps to conducting a proper mock inspection. On day one, hold a meeting to discuss inspection logistics and plan a tour of the facility. Next, you'll need to review management procedures. Make sure you have all necessary documentation on hand to help answer questions. Next are personnel and supplier interviews and evaluations. On the last day you’ll hold more interviews, review outstanding compliance requirements, and discuss next steps.

 

A big part of any FDA audit is the facility inspection. You can help ensure your facility is always inspection-ready by partnering with Assured Environments for regular preventative maintenance. We’ll make sure you’ve got all the paperwork you need for your binder, too.

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