If the FDA inspected or audited your facility and issued you a Form 483, with observations related to compliance issues, don't panic...we will help!
We are experienced in all aspects of FDA Dietary Supplelment inspections and compliance and we'll guideyou through the resolution process.
A well-written FDA Form 483 response can help prevent further regulatory action by the FDA, including a Warning Letter, or worse, rejection of product approval, a product recall, or a plant shut-down.
We'll help you construct a comprehensive response to a Form 483, that:
• addresses each observation
• provides a timeline for correction
• requests clarification of the FDA requirements
FDA Form 483 responses must be submitted within 15 business days, so if you'd like assistance, please contact us immediately.
FDA Warning Letters are serious! They are warnings that the FDA has found that one or more of your practices, processes or products is in violation of FDA requirements and the FDA is prepared to take action.
An FDA Warning Letter is typically issued because an issue that was found during an FDA inspection was egregious or because an observation on the FDA Form 483 was never properly addressed.
FDA Warning Letters give you the opportunity to take corrective measures to prevent further enforcement actions.
A well-crafted, thorough response to a Warning Letter can mean the difference between the issue being resolved, or products being seized and facilities being shut down. In addition, FDA Warning Letters are published on the FDA's website and are available for the public to review. At FDA Compliance Group, we have FDA consultants who have worked for the FDA for decades and are experts in the compliance process.
If you'd like assistance in responding to an FDA Warning Letter, please contact us immediately.