Top 3 Food Safety Plan Issues Cited by FDA During Inspections

Under the Preventive Control Rules, most food and beverage facilities that operate in the U.S. or export to the U.S. market must develop and implement written Food Safety Plans using the Hazard Analysis and Risk Based Preventive Controls (HARPC) method mandated by the U.S. Food and Drug Administration (FDA). 

A complete Food Safety Plan must have multiple components, including a section that identifies hazards and one that identifies controls for those hazards. Now that all Preventive Controls compliance dates for human food (and most for animal food) have passed, FDA is likely to review a facility’s Food Safety Plan during an inspection. If the inspector finds any components missing from a facility’s Food Safety Plan, it can lead to a citation. Here are some of the most commonly cited problems during inspections in 2018 and 2019:

Failure to Identify a Hazard that Requires a Control

Food production hazards come in many forms and without considering all the possibilities, it can be easy to overlook one. FDA requires facilities, under the oversight of a preventive controls qualified individual, to identify all hazards that are ‘known or reasonably foreseeable biological, chemical (including radiological), and physical hazards’ for each type of food manufactured, processed, packed, or held at that facility.

  • Biological Hazards– these can be caused when harmful microorganisms are present in a food product. These can be bacteria, viruses, or parasites. They can be caused by the environment or from inadequate sanitation practices. Cross contamination can also occur during transportation, handling, processing, and storage
  • Chemical/Radiological Hazards– chemical contamination can come from a variety of sources including the environment, the addition of pesticides or drugs, chemicals introduced from manufacturing, or through the addition of unapproved food additives or food allergens
  • Physical Hazards– these hazards are extraneous materials inadvertently introduced into food such as metal fragments, pieces of plastic, wood chips, or glass

These hazards can occur naturally, be unintentionally introduced, or intentionally introduced for economic gain. Every process step must be analyzed for these hazards for each type of food processed at a facility. The hazards will be dependent on the type of product and how it is produced. The results of the hazard analysis will determine which preventive controls are necessary. To be sure you don’t miss a required hazard, make sure to consider all possible types of hazards and scenarios.

Failure to Identify a Preventive Control When One was Needed

After identifying a potential significant hazard, it is required to have a control in place to eliminate or minimize that hazard. There is some flexibility in what that control can be, and it will be dependent on the type of product and how it is manufactured. These preventive controls must be written and then implemented to ensure the product is safe. All stages of the production process should be considered. Examples of preventive controls include:

  • Process controls– any procedure or practice in the facilities’ operations, such as making sure temperatures are maintained appropriately for heating or cooling or acidifying or irradiating a product correctly
  • Food allergen controls– this can include preventing allergen cross-contact during the storage, handling, or use of a food product and labeling the food product appropriately according to the Food Allergen Labeling and Consumer Protection Act (FALCPA)
  • Sanitation controls– facilities, especially those that make ready-to-eat products, must maintain cleanliness of any food-contact surfaces, equipment or utensils associated with the production process, as well as prevent cross-contamination from raw or processed products
  • Recall Plans– facilities that produce food for which a hazard has been identified must have a recall plan
  • Other Controls– all procedures, practices, and processes should be considered in establishing whether a step is a preventive control for example, hygiene training may be required or other good manufacturing practices 

Preventive Controls Records Did Not Meet General Records Requirements

Creating your facility’s Food Safety Plan does not end with identifying hazards and putting controls in place. FDA requires extensive record keeping to ensure that the Food Safety Plan has been properly implemented and remains effective and consistent. Records that must be kept include:

  • Documentation on the basis for not establishing a preventive control for an identified hazard
  • Documentation on the monitoring of Food Safety Plan preventive controls
  • Documentation of any corrective actions taken
  • Documentation on all verification activities which can include verifying process controls, calibration of instruments, product testing, environmental monitoring, and reanalysis of the Food Safety Plan
  • Documentation of all relevant training for employees and Preventive Controls Qualified Individuals

These records must be detailed and must be created concurrently with the respective action. All records must be kept for a minimum of two years. These records aim to maintain your Food Safety Plan while keeping it effective, especially when changes are made to the production process.

Registrar Corp is a private company that assists businesses in complying with FDA. Our Food Safety Specialists are PCQIs and can assist your facility in developing a HARPC food safety plan as well as conduct a mock inspection of your facility to help you prepare for an FDA inspection. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at

Don’t wait! Renew your
FDA registration today.

Registrar Corp will help you re-register with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email:, or chat with a Regulatory Advisor 24-hours a day:


Subscribe To Our News Feed

To top