The Canadian over-the-counter drugmaker Pax-All Manufacturing has been banned by the FDA from shipping any of its products into the U.S. until it cleans up its act.
A warning letter to the Ontario company, which sells to dollar stores, cited loose manufacturing practices and the use of duct tape and cardboard used to fix a problem, reports the Globe and Mail.
Mario Merino, Pax-All's vice-president, says the company, which also makes cosmetics, is addressing FDA concerns, but he also called the action "absurd," claiming the FDA was playing favorites. He says he believes facilities in Asia get less oversight than his.
The FDA dismissed his accusation. FDA spokeswoman Shelly Burgess told the Globe and Mail: "We just don't target one company and not others. Someone who has received a warning letter will of course try to deflect the attention away from them."
And if the FDA was going to play favorites, you might expect it to be easier on facilities in the U.S. Merino didn't seem to take into account the Novartis ($NVS) plant in Lincoln, NE, which makes mostly OTC products. It has been closed since December and working to again win FDA approval.
- read the Globe and Mail story