Fda Recall Case Study

The FDA instructed the firm to inform all the distribution channel about the recall in a writing form. FDA recommends that you include the following information in a recall notification:
1) Product identification
2) Description of the problem
3) Depth of the recall
4) Instructions to the customer. The instruction should be clear and in written format and must include the following data:
a. Remove product from sale
b. Cease distribution
c. Subrecall
d. Return product
e. Explain procedure for product correction
c) Evaluation of the recall. Finally, the firm needs to provide FDA with information about the recall. The evaluation must include the following information:
1) Effectiveness of the recall
2) Recall status reports
3) Root cause of the problem that resulted in a recall
4) Corrective actions to …show more content…
In general, the manufacturer is obligated to inform the customer about the issue. In this document, the manufacturer describe the safety-related defect or noncompliance with a Federal motor vehicle safety standard, which models/products are affected with the problem, a description of how the company will process the recall. In the automotive case, the dealers are the point of contact with the end users and usually the process includes a replacement of the part/component in risk. The information contained in the notification letter must be:
• Description of the defect or noncompliance;
• The risk or hazard posed by the problem, including any warning of the problem;
• A brief description of the free remedy, including when the remedy will be available and how long the repair will take; and
• A description of what the owner can do if the owner is unable to have the problem corrected within a reasonable time and without