Food manufacturers are seeing a sharp increase in FDA inspections, especially outside the U.S. since the pandemic. Many of these inspections are unannounced and focus on the Food Safety Modernization Act (FSMA) requirements. If you are a Preventive Controls Qualified Individual (PCQI), your ability to maintain a ready facility can help prevent violations and protect your business.
Having an up-to-date PCQI training certificate is the first step to staying compliant. With PCQI training online from ImEPIK®, your food safety team can be audit-ready at any time.
Can the FDA Inspect Without Notice?
Yes. Under FSMA, the FDA has full authority to conduct unannounced inspections of food facilities. You will not receive a warning or notification in advance. Inspectors can show up at your door and request access to your facility, processes, and records.
Unannounced inspections are most common in domestic facilities that manufacture, process, pack, or hold human food. As a PCQI, you are responsible for ensuring your food safety plan and records are always current and accessible.
One of the quickest ways to fail an inspection is not having required documentation ready. Completing PCQI training online equips you with the skills to manage these FDA visits with confidence. The PCQI training certificate demonstrates that you meet FSMA's training requirement for leading food safety activities.
What Triggers an FDA Audit?
Several factors can cause the FDA to audit your facility. Here are the most common triggers:
- Routine FSMA Inspection Cycles: Even without any issues, your facility will undergo regular inspections.
- Consumer Complaints: Reports of illness or injury related to your product can trigger a visit.
- Recalls: If your facility has experienced a product recall, you can expect a follow-up inspection.
- Positive Environmental Samples: The FDA collects samples during inspections, and positive pathogen findings can lead to enforcement action.
Previous Violations: If you've received a 483 observation or warning letter in the past, you may face more frequent inspections.
Having a qualified PCQI who manages preventive controls, recordkeeping, and corrective actions helps reduce these risks. A PCQI with current training ensures your food safety program aligns with FDA expectations.
How to Get Ready for an FDA Audit
Staying inspection-ready is easier when your PCQI follows these clear steps:
- Keep Your Food Safety Plan Current: Review and update your plan anytime you add new products, processes, or equipment. Annual reviews are a minimum requirement.
- Conduct Internal Audits and Mock Inspections: Practice answering inspector questions and reviewing records. Internal audits will highlight weak spots before the FDA does.
- Organize Records and Keep Them Accessible: The FDA will expect to see records like hazard analysis, preventive controls monitoring, and verification activities. Have digital or well-organized paper records ready.
- Maintain PCQI Training Records: Your PCQI training certificate must be available during the inspection. Completing PCQI training online ensures your team is up-to-date without costly travel or time away from the plant.
Why PCQI Training is the First Step to Audit Success
Training is the foundation of a successful food safety program. Under FSMA's Preventive Controls for Human Food rule, every FDA registered facility must have a PCQI named in the food safety plan who has successfully completed FDA-recognized training or is otherwise qualified.
ImEPIK® PCQI training online offers:
- Self-paced modules you can complete on your schedule
- 100% online access with no travel required
- English and Spanish options
- Certificate of completion recognized by the FDA
- Compliant with FDA FSMA, SFCR preventive controls, and BRCGS
Whether you are a new PCQI or need to refresh your skills, ImEPIK® provides everything you need to stay compliant.
Stay Prepared Before the FDA Arrives
Unannounced FDA inspections are happening more often. Small and mid-sized food manufacturers cannot afford to be caught off guard. By earning your PCQI training certificate and keeping your food safety plan up to date, you will be prepared when inspectors arrive.
With ImEPIK® PCQI training online, you and your team can build confidence and protect your facility from violations. Don't wait for the knock on the door—register now for PCQI training.
