Pax-All VP Blasts FDA

Pax-All VP Blasts FDA

April 4th, 2012 // 1:23 pm @ jmpickett

Source: Pharmalot

Some guys have all the bad luck, right? At least, that’s how Mario Merino, the vice president at Pax-All Manufacturing, an over-the-counter drugmaker in Ontario, Canada, feels these days. When asked about a warning letter from the FDA, which is maintaining a ban on allowing Pax-All products into the US, he complained the agency is picking on him. Pax-All makes deodorants, chest rubs, petroleum jellies, soaps and cosmetics.

At first, actually, he was demure, preferring not to discuss the problem when a journalist from The Globe and Mail asked about the FDA letter. “We’re producing the documents the FDA requested. I want to resolve the issue before we say anything,” Merino maintained. But then he changed his mind and decided to say how he really feels about the agency that so many love to hate.

“It’s absurd,” he said, that the FDA has targeted Pax-All, which must suffer “hassles and inspections” that manufacturers in other regions, namely Asia, do not have to endure. “It’s because we’re (geographically close to (the FDA),” he complained to the newspaper (see here). “It’s easy for them to inspect us. They don’t go there (to Thailand and China).”

Actually, the FDA has a presence in China, although the agency has been heavily criticized for not conducting more oversight there in the wake of the heparin scandal. The White House recently proposed a $4.49 billion budget for the FDA for the year beginning October 1, which would amount to a 17 percent boost. About $10 million would be used to hire 19 inspectors to focus on China, with 16 focusing on food and drug safety and standards.

Not surprisingly, an FDA spokeswoman tells the paper the agency “doesn’t discriminate” in its investigations. “We just don’t target one company and not others,” she says, adding that the FDA takes “a risk-based approach depending on the level of risk involved and how severe the potential violation would be to the consumer… Someone who has received a warning letter will, of course, try to deflect the attention away from them.”

Could this be possible? Well, Pax-All did fail more than one inspection, which is why its products remain on an Import Alert. But what went wrong during the most recent visit, which took place last September? Believe it or not, Pax-All repaired and redesigned its filling line using clear and duct tape, and torn pieces of corrugate cardboard boxes, according to the March 9 warning letter (read here).

In a bit of understatement, the FDA writes “these materials are not suitable materials of construction or easily cleanable, and are not adequate for the manufacture of drug products.” Hmm… And Merino believes Pax-All is being picked on? Then again, perhaps Pax-All uses a better quality duct tape and cardboard box to repair equipment than manufacturers in Asia (here is a picture of the plant; please tell us if you spot any duct tape).

What else? Between September 2009 and September 2011, Pax-All distributed batches of products to the US, some of which were not tested according to finished product specifications. And Pax-All did not have a written testing program to verify stability or follow “written procedures designed to assure that correct labels, labeling and packaging materials” are used for its products.

This is not the first time that Pax-All has run into trouble with the FDA. A 2007 Import Refusal report lists several items that appeared to lack adequate directions for use and lacked an approved new drug application. There also appeared to be insufficient warnings against use in a pathological condition or by children where it may be dangerous to their health or against an unsafe dose, method, administering duration, application to protect consumers