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What companies need to register with the U.S. Food and Drug Administration (FDA)?

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According to Jacob Hencke, a senior Environmental, Health and Safety (EH&S) consultant with ERI Solutions LLC., any company that packages, holds, produces or otherwise distributes animal food or food for consumption needs to register with the U.S. Food and Drug Administration (FDA).

The FDA website explains that part of that registration includes the assurance that the FDA will be permitted to inspect the facility at times and in the manner permitted by regulations. Additionally, the registrations must be renewed each year.

Why Your Company Needs a Food Safety Plan (FSP)

In addition to registration with the FDA, your company must comply with the Food Safety Modernization Act (FSMA), which includes having a Food Safety Plan (FSP).
An FSP consists of the primary documents in a preventive controls food safety system. According to the FDA, the documents in an FSP include:

  1. Hazard analysis to identify whether there are hazards requiring a preventive control.
  2. When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the following written documents:
    1. Preventive controls to ensure safe food is produced
    2. Procedures for monitoring the implementation of the preventative controls
    3. Corrective action procedures
    4. Verification procedures

How a Compliance Assessment Will Help

While registering with the FDA should be fairly straightforward, complying with FSMA by having an FSP with all needed documents can be more complex. Many companies have chosen to partner with ERI Solutions in order to have an FSMA compliance assessment.
A compliance assessment from an outside consultant is highly recommended as it can identify potential areas of non-compliance that can be resolved prior to the FDA inspection.

About ERI Solutions

ERI Solutions is uniquely positioned to ensure companies like yours are protected from unnecessary risks related to regulatory non-compliance, employee injury, liability and property damage. We work within a variety of industries and have clients throughout the United States with whom we have conducted FSMA compliance assessments.

Find out more about our Safety Services or contact ERI Solutions directly at (316) 927-4290.

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