James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Corporate Counsel, in “$42M Rat-Infestation Fine Underscores Sanitation Risks Facing Warehouses,” by Chris O’Malley. (Read the full version – subscription required.)
Following is an excerpt:
The record $41.7 million penalty levied against the Dollar Tree retail chain last week for a rodent infestation at its Arkansas warehouse serves as a chilling lesson for companies making or selling Food and Drug Administration-regulated products.
Lawyers say the criminal fine, the largest ever assessed by the Justice Department in a food safety matter, underscores the need to continually assess processes and readiness of sites well-ahead of a visit by FDA agents, who descended on the West Memphis, Arkansas, distribution center in 2022.
Self-assessment is especially important, as some companies grew complacent or lost key personnel since the slowdown in FDA inspections during the pandemic.
One useful tool for inspection readiness is to periodically conduct mock audits of a site’s quality management and current good manufacturing practice controls …
James Boiani, a member of Epstein Becker & Green, also is a proponent of mock audits. He often goes to a client’s site with consultants in tow to identify gaps that might not be obvious otherwise.
“In the event the FDA comes in, you either have the problem corrected, or you have identified it yourself” and can create a corrective-and-preventative action plan, Boiani added.
The FDA might still have questions, but by implementing such a plan, “you’re less likely to get dinged with more severe penalties. … It’s a really helpful way to de-risk potential problems that come up.” …
Companies also should come up with a plan for responding to inspections, such as identifying key individuals ahead of time who should be available. Companies need to be able to put themselves in the best light when the FDA arrives. Being able to quickly produce records when asked for by inspectors is one way, Boiani emphasized.
