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Warning Letters

FDA-issued warning letters are usually the FDA’s first course of action against companies for alleged non-compliance with the FFDCA and/or FDA regulations. Per the written terms of warning letters, the FDA gives recipients fifteen (15) business days to respond in writing, detailing the specific steps taken to correct violations the FFDCA and accompanying regulations. Firms must respond to all violations, including those not explicitly cited in warning letters. Accordingly, it is important to determine what regulatory issues prompted the FDA’s action in order to respond fully. Finally, it must be noted that firms must not only detail how they will correct alleged deficiencies, but they must also take all steps necessary to correct these issues.

FDA Enforcement and Warning Letters

While warning letters are considered an informal mechanism of FDA action, the failure to respond appropriately may often result in more formal measures being taken against non-compliant firms. Because appropriate corrective measures often preclude further enforcement, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance. Accordingly, a FDA regulatory lawyer can allow you to develop responses to warning letters that can help you avoid further FDA enforcement.

Responses to Warning Letters

At Shehadeh Giannamore, PLLC, a FDA regulatory lawyer can help you respond to

FDA warning letters by:
  • Reviewing the legal and regulatory basis for your warning letters;
  • Determining the appropriate measures that need to be taken in order to reestablish compliance with federal laws and/or FDA regulations;
  • Drafting and preparing a response to warning letters, within the time-frame necessary;
  • Communicating with the FDA on your behalf with respect to the warning letters and your regulatory commitments, and
  • Helping you ultimately achieve compliance by providing guidance as to the necessary corrective measures.
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