Recalls and Corrections2018-09-04T14:25:44+00:00

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 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

We service all sized companies and classifications within your budget.

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