The following is a letter from FDAImports.com Founder and CEO, Benjamin England:
As you may know, Diamond Pet Food Processors issued multiple product recalls over the last two months. On April 12, only six days after Diamond’s first recall, FDA conducted a weeklong inspection of Diamond’s facilities and found numerous violations. Finally, a few weeks ago, a law firm filed what is believed to be the first lawsuit against Diamond. The lawsuit, filed on behalf of an infant sickened by Salmonella, explicitly cites the results of FDA’s inspection as evidence of Diamond’s negligence. Don’t let this happen to you.
If Diamond had adequately complied with FDA’s regulations, they would not have nearly the troubles they do now – and I expect their troubles will escalate. Even if they still experienced this contamination event they would be able to highlight the good results of an FDA inspection, which would help at least with PR and with settling the specific lawsuit. The next (potential) shoe to drop is the shareholder derivative action alleging, however accurately, that the company failed to disclose these kinds of FDA compliance-related issues that led to the contamination (and ultimately the illness, the recall and the rapid share descent).
As most of you know, I am a 17-year veteran of the FDA. I founded FDAImports.com to help domestic and foreign companies of all sizes comply with the myriad of regulatory requirements related to the FDA and other federal and state agencies. Complying with all applicable regulations not only helps reduce the risk of regulatory interference with your operations but also mitigates the risks of these types of lawsuits. If you happen to find yourself facing agency enforcement actions such as inspections, warning letters, FDA import detentions or refusals or even government civil or criminal investigations, we can help stop (or significantly slow) FDA in its tracks and get you back on track growing your business.
Don’t make the mistake of thinking this happens to the other guy. It happens to whom it happens to, and it could be your company. One unfortunate event can bring the entire weight of the federal government to bear upon your door.
– Ben England
