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Guide to Handling FDA Food Inspections, 2nd Edition

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Authored by Olsson, Frank & Weeda, P.C.

The Guide To Handling FDA Food Inspections is intended to help you and your company deal with the Food and Drug Administration’s regulatory inspections of food processing operations as well as inspections of warehouses, shippers and retail establishments. It is essential that all such establishments understand their rights and responsibilities with respect to FDA inspections, and have in place a detailed plan to prepare for and respond to such inspections. (122 pages, published 2005)

 

You Have Rights!

 

Do you know what your rights are if an FDA inspector asks you to:

 

  • Sign an innocuous sounding affidavit or statement regarding the inspection
  • Give permission to take photographs inside your plant.
  • Question anyone other than your inspection coordinator
  • Inspect manufacturing records of products you produce
  • Take a sample of your product

 

Not knowing the answers to any of these questions can impact your business and your bottom line.

 

Setting Ground Rules

 

This Guide will help you develop inspection policies to set the ground rules regarding certain matters that are within your company’s discretion -- some of which you may not even know about. A number of these issues, such as whether you would like to maintain an "open-book" policy toward the inspector or to restrict FDA to no more than which they are legally entitled, should not wait to be answered until the FDA inspector is ringing your doorbell.

 

What You Need To Know

 

The Guide To Handling FDA Food Inspections covers a number of areas that food industry management and executives need to understand, including:

 

  • FDA Inspection Authority
  • Reasons for an FDA Inspection
  • Preparing for an FDA Inspection
  • The Inspection Itself
  • Post-Inspection Follow-up
  • FDA Enforcement Options
  • Special Types of Inspections
  • And special settings, such as retail establishments and overseas facilities

 

Also included are:

 

  • Sample forms from FDA
  • A directory of FDA’s Office of Regulatory Affairs
  • Recent Statistics on FDA Food Inspections and Enforcement Actions

 

Customize Your Plan

 

Every food company should have this Guide in order to fully understand and be ready for a visit by an FDA inspector, taking into account to firm’s specific circumstances and needs.

By following the steps spelled out in our Guide, an FDA inspection should occur with a minimum of disruption and leave the government inspector with the impression of a well-organized, safe and efficient operation.

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