FDA Inspections

Proactively prepare for FDA inspections.
Immediately address non-compliance and automatically save data.

Why are FDA inspections necessary?

The US Food and Drug Administration (FDA) inspects regulated facilities to ensure their compliance with the laws and good manufacturing practice regulations surrounding the manufacture, labeling, and handling of food, drugs, medical devices, and cosmetics that are commercially distributed in the US. FDA inspections are conducted on both local and foreign establishments as long as the products are intended for US distribution. Also, new drugs and biologics require FDA approval before they are introduced to the US market.

Types of FDA Inspections

The FDA prioritizes the inspection of companies that manufacture high risk drugs and equipment. Newly registered establishments and those that have past violations are also given priority for FDA inspections. Here are 4 types of FDA inspections that manufacturers can expect:

  • Pre-approval– an inspection that is conducted when there’s an application to market a new product;
  • Routine– the standard inspection conducted once every two years for domestic establishments and around once every 9 years for foreign facilities. If violations are found but corrective actions are immediately taken to address the issues while the FDA inspector is present, this will be noted as a positive indicator of the establishment’s commitment to stay compliant;
  • “For-cause”– an inspection intended to investigate issues or concerns that have been brought to the FDA’s attention; and
  • Compliance follow-up– if violations are found during an inspection, an FDA Form 483 will list the violations and the FDA will return to reinspect to confirm if corrective actions were taken to rectify the issues previously observed.

Inevitable but can be prepared for

FDA inspections are inevitable but you can prepare by proactively conducting regular internal audits so that compliance gaps can be found and immediately corrected. Conducting regular internal audits, however, can be time-consuming and tedious if the business is dependent on paper-based documentation. Proof of sound Good Manufacturing Practice (GMP) would require manually collecting and sorting through documents from multiple sources. Time spent on paper-based inspections and manual documentation could’ve been better spent correcting non-compliance before the actual FDA inspection happens.

iAuditor, the world’s #1 mobile inspection app, can help you conduct paperless internal audits and immediately assign tasks for urgent issues found. Check the current compliance status of your facility by tracking the overall trend of measurable audit results. Conveniently share information anytime anywhere and review historical data on one online platform.

To save you time, we have carefully collected and converted these free downloadable digital checklists you can use on the iAuditor mobile app to prepare for the FDA inspection: