The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. … The law grants the FDA a number of new powers, including mandatory recall authority. A recall is when a product is removed from the market or a correction is made to the product because it is either defective or potentially harmful. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns.
There is no hard and fast answer without knowing the situation and circumstance, but JAD can provide you with answers to your concerns-this will prevent if nothing else a panic.
Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation.
Recalls: Actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
- Class I: There is a reasonable probability that the use of or exposure to a violated product will cause serious adverse health consequences or death.
- Class II: Use of, or exposure to a violated product may cause, temporary or medically irreversible adverse health consequences, or the probability of serious adverse health consequences is remote.
- Class III: Use of, or exposure to a violated product is not likely to cause adverse health consequences.
Recall Management
With JAD Regulatory Consulting Inc. you get the actual U.S. Food & Drug Administration investigators that were involved with Recalls, so we can provide guidance on recall management for your foreign or domestic manufacturing plant. We can develop the recall plan and all required documentation. We can be at your establishment when the U.S. FDA arrives for a recall and we can be a liaison between the U.S. FDA and your company.
