RECALLS AND CORRECTIONS
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 strategyHealth hazard evaluation
Coordination with FDA district office
Stock recovery – degree and depth of recall
Recall letter
Public warning
Recall status reports
Effectiveness checks