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FDA Food Recalls: What Food Manufacturers Should Review in Their Hazard Analysis and Preventive Controls

1. Revisit the hazard analysis

Evaluate known or reasonably foreseeable biological, chemical, physical, and allergen hazards based on the food, facility, process, and intended use.

2. Evaluate preventive controls where required

Determine whether identified hazards requiring a preventive control are addressed through appropriate process, allergen, sanitation, or supply-chain controls, as applicable.

3. Check monitoring and corrective action

Confirm procedures identify what is monitored, how often, who is responsible, and what actions are taken when implementation problems occur.

4. Review verification and validation

Determine whether validation is required for the control and whether verification activities, record review, calibration, and other checks are appropriate.

5. Assess reanalysis triggers

Evaluate whether new information, significant changes, or other events trigger food safety plan reanalysis under applicable requirements. Document the basis and outcome.

How Consultare Inc. Group Can Help

Consultare can provide food safety plan and hazard analysis review, preventive controls gap assessments, allergen and sanitation control review, monitoring and verification procedure development, corrective action support, and PCQI-related technical assistance. Requirements and service scope depend on facility coverage, exemptions, product type, and the specific preventive controls rule.

Free Consultation

Need Help Managing Your PCQI Responsibilities?

Whether you are developing a food safety plan, reviewing hazard analysis, implementing preventive controls, or determining whether your procedures and records are adequate, request a free consultation through PCQIServices.com. Discuss your facility, products, food safety plan, and preventive controls questions with the team. You can also create a free SystemsBuilder account to organize compliance documentation and processes.

Start Building Your Compliance System

If you prefer to organize and manage your compliance activities yourself, you can also create a free SystemsBuilder account and begin building a structured system for your compliance documentation and processes.

The right time to review your controls, documentation, and response process is before a product safety concern becomes a business problem.