Question
Your client contacts you. The FDA has sent them a sign or sue letter. In part, the proposed consent decree includes the following: The proposed
Your client contacts you. The FDA has sent them a sign or sue letter. In part, the proposed consent decree includes the following:
- The proposed defendants are the company, and then individually the owner, the plant manager, and the operations manager.
- The food is adulterated because of the failure to control allergens, specifically nuts.
- They want your client to stop producing all products at the facility until:
- The client hires an expert to develop and implement a plan to control allergens from getting into foods for which they are not declared.
- A third-party auditor submits a report to the FDA that the client is in compliance with the plan that was developed.
- The client has destroyed all the food products previously manufactured
- If your client violates the terms of the consent decree:
- FDA can assess monetary penalties
- FDA can shut down production until it decides your client is in compliance again
- The consent decree will be in place for five years or until your client has had three compliant FDA inspections, whichever is longer.
Your client is the owner, they have disclosed to you that the plant manager has put in their resignation and they have signed a retention agreement with the operations manager to ensure that there is continuity of knowledge to keep operations going.
Your client produces a number of confectionary products, some of which contain nuts and some which do not. The ones that contain nuts are appropriately labeled with allergen information. The FDA is concerned that products that should not contain nuts are being contaminated during processing.
Identify one point you would like to negotiate with FDA in this consent decree that you think they would be agreeable to negotiating. Explain your reasoning for why you selected this point as a priority for your client. Describe what arguments you would make to FDA on behalf of your client to change the terms of the consent decree to be more favorable for your client.
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