FDA Recalls
We can assist parties, with FDA Recall issues
Recalls
Whether a recall is mandatory or voluntary, product recalls can be severely disruptive, time-consuming, costly, and stressful. Businesses must balance complying with FDA regulations, protecting consumers, limiting supply chain disruption, and avoiding the business’ reputational harm. Garg Law can assist in managing FDA recalls. On the compliance side, this includes developing and implementing a recall policy. On the enforcement side, this includes assisting with recall classification, potentially limiting scope of the recall, and working with the FDA to execute and successfully terminate the recall
Background on Recalls
Recalls represent ways to remove or correct products that are in violation of FDA’s laws, oftentimes related to a labeling or quality issue. We unfortunately see regular recall announcements in the news, involving a range of compliance issues such as allergen labeling, presence of a foreign object, or potential bacterial contamination.
FDA has a three-tiered recall classification structure based on risk that use or exposure to a possibly non-compliant product will cause adverse health consequences. Based on the recall classification, notification may involve public press releases or more direct and private customer notification. This naturally can affect the businesses’ reputational harm, so navigating it carefully is critical. There are also factors that guide recall strategy and the decision to make a recall, as well as systems that should be in place to be “recall ready.”
How Garg Law Can Help:
With our expertise in FDA recalls, Garg Law can assist you with the following:
- Managing recalls involving FDA-regulated products
- Assisting with preparing for recalls, providing critical advice early in the decision-making process to help reduce impact on your customers and business
- Assisting in drafting recall plans
- Working with FDA to successfully execute recalls while minimizing business disruption
While a recall is always an unfortunate event, how you manage the legal, regulatory and business parameters of a recall can make or break moving forward and continuing to grow your business. Call today for a consultation to discuss how to be recall ready or how to successfully navigate your recall.
