Can Your Training Records Survive an FDA Audit?
When it comes to food safety compliance, most facilities focus on sanitation, preventive controls, and supply chain verification. But one often-overlooked area can trigger immediate FDA scrutiny during an inspection: employee training records. Under 21 CFR §117.4, part of the Food Safety Modernization Act (FSMA), the FDA mandates not only proper training for all personnel but also verifiable documentation to prove compliance.
What Does 21 CFR §117.4 Require?
The regulation states that all individuals engaged in manufacturing, processing, packing, or holding food must receive training in:
- • Principles of food hygiene and food safety
- • Personal cleanliness and appropriate practices
- • Regulatory expectations and Good Manufacturing Practices (GMPs)
- • Who was trained
- • What topics were covered
- • When the training occurred
- • Who conducted the training
What Happens If Records Are Missing or Incomplete?
Facilities that fail to present adequate training records can face:
- • FDA Form 483 observations
- • Warning Letters
- • Risk of recalls or product seizures
- • Ineligibility for third-party audits (e.g., SQF, BRC, GFSI)
How PCQIServices.com Helps You Stay Compliant
At PCQIServices.com, we provide a Qualified Personnel & Training Records Compliance Program designed to meet FDA expectations while keeping your operations audit-ready.
Our program includes:
- ✅ Onboarding & refresher training aligned with FSMA
- ✅ Digital tracking of training certifications and renewals
- ✅ Customizable training logs and SOPs
- ✅ Auditor-ready documentation and retrieval system
- ✅ Periodic reviews to maintain up-to-date compliance
Don’t Wait for the FDA to Come Knocking
Training compliance is not just a box to check—it's a legal requirement and a pillar of food safety culture. Protect your brand, your product, and your license to operate by investing in a proactive training documentation system.
Start your training compliance journey today with PCQIServices.com.