In the unfortunate event of a recall, EAS consultants can walk your company through the steps of the recall process, including traceability, 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.
A product recall can be one of the most time-consuming and expensive occurrences for a business but is required when a product is found to be either defective or potentially harmful. Whether the recall is voluntary or requested by FDA or other agencies, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.
From ingredient/component suppliers to manufacturing /processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall.
EAS 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. Call EAS and trust that your recalls will be conducted correctly.
FDA Recall Assistance
Recall Procedural Reviews
Recall Prevention Strategies
Facilitating Communication with FDA
Got a Question?
Contact Us Today for a Complimentary Consultation!