As of June 18, the FDA will be increasing fines for regulatory noncompliance. The 2014 update will be the first since 2008, and will be based on inflation rates as determined by the Consumer Price Index (CPI). Adjustments may not exceed 10% of the total penalty and will range from $200 to $11 million depending on the offense.
FDA monetary penalties are just one cost that companies must factor in when calculating the total cost of a product recall.
Recall management costs vary depending on factors such as scale, scope, and type of recall. Unexpected expenses can quickly add up. For starters, companies need to understand the factors that drive total
product recall costs. They include: