FDA requires a recall when an FDA-regulated product is either defective or potentially harmful. The recall may require removing the product from the marketplace entirely or taking corrective actions to fix the problem. Whether a recall is voluntary or required by FDA, it is FDA’s responsibility to oversee and confirm the adequacy of the process in order to protect the safety of the U.S. marketplace.EAS Consulting Group, LLC. can help with recall prevention strategies through audits of Good Manufacturing Practices (GMPs), review of labeling and health or disease claims on packaging and marketing materials as well ingredient and toxicology reviews and appropriate filings and documentation. EAS can also assist with the performance of a mock recall to assess your readiness to execute an actual recall.
In the unfortunate event of a recall, EAS consultants can help walk your company through the steps of the recall process to ensure FDA compliance. Whether the infraction is a Class I, II or III recall, EAS can assist in making this challenging process more streamlined and act as a conduit of information between your company and FDA.