A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective

Recalls may result from your 483 Observations or from a Warning Letter. Like all responses to the FDA, a Recall must be comprehensive and exhaustive in removing all recalled product from distribution.

Smith Associates can provide the assistance to your company for:

• Recall strategy
• Health hazard evaluation
• Coordination with FDA district office
• Stock recovery – degree and depth of recall
• Recall letter
• Public warning
• Recall status reports
• Effectiveness checks