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Types of Food and Drug Administration Inspections The primary goal of an FDA inspection is to protect consumer well-being by ensuring that only safe-to-use products are released to the market. Third parties’ use of or acknowledgment of the tool and its accompanying documentation does not in any way represent that FDA endorses such third parties or expresses any opinion with respect to their statements.New products require FDA approval before they are introduced to the US market, which is why “FDA inspection readiness” should be a priority for companies. 2.0 and of the accompanying documentation lies solely with the user. Responsibility for the interpretation and use of the Food Defense Plan Builder v.
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#Fda product builder update#
FDA is not making a commitment in any way to regularly update the tool and the accompanying documentation.
#Fda product builder download#
The Food Defense Plan Builder and the accompanying documentation are available for download “as is” and without warranties of any kind, either expressed or implied, including, but not limited to, warranties of performance, merchantability, and fitness for a particular purpose. However, FDA is not responsible for errors, omissions or deficiencies regarding the tool and the accompanying documentation. 2.0 and the documentation accompanying it. FDA has taken all reasonable precautions in creating the Food Defense Plan Builder v. FDA does not track or monitor its use and does not have access to any content or documents saved using this tool. 2.0 is a desktop tool that resides only on the user’s computer. 2.0 is consistent with the Food and Drug Administration’s (FDA) existing regulations and guidance, use of the Food Defense Plan Builder v 2.0 does not constitute FDA approval of a food defense plan or guarantee compliance with FDA’s requirements. A written food defense plan is essential for you to significantly minimize or prevent significant vulnerabilities related to intentional adulteration of food.Īlthough the content of the Food Defense Plan Builder v.
#Fda product builder verification#
A food defense plan is a set of written documents that is based upon food defense principles and incorporates a vulnerability assessment, includes mitigation strategies, and delineates food defense monitoring, corrective action, and verification procedures to be followed. The Food Defense Plan Builder (FDPB) version 2.0 is a user-friendly tool designed to help owners and operators of a food facility in the development of a food defense plan that is specific to their facility and may assist them with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121).
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