Inspections can be a double-edged sword, depending on how prepared you are for the Food and Drug Administration (FDA) and to address any non-conformances they identify.

Some plant managers view inspections as a hassle and begrudgingly guide Food and Drug Administration officials through their facility and records. In contrast, others welcome the opportunity to showcase their food safety programs and the personnel responsible for implementation.

Having a Well-Established Food Safety Culture is Paramount

To foster a food safety culture in all departments and levels, company officials must demonstrate that they believe inspections and audits are necessary and provide value. That’s true even when an inspector finds a deficiency that requires a food safety plan update or employee training.

This blog from ImEPIK looks at the top non-conformances tallied by FDA inspectors during Fiscal Year 2021, which ended Sept. 30, 2021. The non-conformances are reported through FDA Form 483, which is filled out when investigators observe conditions they consider to be objectionable.

Lack of Import Programs Overshadows All Other Concerns

This food category generates the most Form 483s by far. Of the 2,472 reports for all areas (including drugs and medical devices), 1,751 were for foods and dietary supplements.

Leading the list by a considerable margin is the failure by importers to have a Foreign Supplier Verification Program (FSVP), which generated almost 800 Form 483s. The next category, concerning pest control programs, generated just 88 of the forms in FY 21.

FDA inspector fills our formThe Food Safety Modernization Act’s FSVP rule requires importers to verify that trading partners in other countries adhere to the same level of food safety that companies must meet in the U.S. That includes conducting a hazard analysis to determine whether imports require a control to mitigate risks.

The lack of FSVPs is also a common reason for warning letters issued by the FDA when non-conformances remain uncorrected. Considering that they are the equivalent of the supply chain programs that identify hazards from domestic suppliers, importers must demonstrate that what they source outside the U.S. is safe.

Pests, Documentation, Sanitation and More: Other Common Food Safety Concerns

The FDA’s list of most-common non-conformances for FY 2021 also includes:

  • Pest Control: Companies didn’t ensure proper pest control or didn’t follow the proper precautions to protect against food contamination from pesticides or pests.
  • Manufacturing, Processing, Packing, and Holding Controls: Companies didn’t operate under conditions and controls necessary to minimize the potential for microorganism growth, allergen cross-contamination, or food contamination.
  • Hazard Analysis: The hazard analysis didn’t identify a known or reasonably foreseeable hazard requiring a preventive control.
  • Lack of Written Hazard Analysis: Companies didn’t have a written hazard analysis.
  • Evaluation of Performance, Risk: There was no documentation that companies conducted an assessment or that a third-party evaluation was conducted to determine the performance of a foreign trading partner.
  • Lack of Foreign Supplier Evaluation: Importers failed to document they had evaluated a foreign supplier’s performance and the risk posed by imported food, whether by the importer or a third party.
  • Sanitary Operations, Plant Maintenance: Facilities weren’t clean and sanitary, or plants were in disrepair.
  • Approved Supplier Procedures: Companies did not establish written procedures to ensure appropriate supplier verification activities were conducted.
  • Equipment and Utensils, Design, and Maintenance: Equipment and utensils were not designed to be adequately cleaned or maintained to protect against contamination/allergen cross-contamination.

Lessons Learned from Other’s Mistakes

Importers should review their FSVP and ensure they can demonstrate that either the company or an approved third party has verified that foreign suppliers meet food safety requirements. The Form 483s also underscore how important it is that manufacturers document all supplier relationships, whether foreign or domestic.

Documentation is a crucial part of a company’s food safety program. Companies that can produce documents to back food safety claims will find that the inspection process is much smoother.

ImEPIK’s Food Safety Training Prepares PCQIs for Inspections

ImEPIK’s online PCQI course is designed to help companies craft food safety programs that fulfill the FDA’s Food Safety Modernization Act requirements. PCQIs, or Preventive Control Qualified Individuals, are instrumental in that process as they not only build food safety programs and plans, they document the procedures and represent the company during inspections.

Contact ImEPIK today to learn more about our 100% online training, and now the PCQI course is also available in Spanish.

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