FDA bans Ontario firm from shipping products to U.S.

FDA bans Ontario firm from shipping products to U.S.

April 3rd, 2012 // 12:15 pm @ jmpickett

An Ontario company that makes cosmetics and over-the-counter drugs has been banned by the U.S. Food and Drug Administration from shipping its wares to U.S. dollar stores until it cleans up its alleged shoddy manufacturing practices.

The FDA accused Mississauga-based Pax-All Manufacturing Inc. in a letter last month of failing to perform adequate product testing, inadequately labelling or documenting its drug products, and having no testing program to assess proper storage conditions or expiry dates. The company makes deodorants, chest rubs, petroleum jellies, soaps and cosmetics.

Health Canada deferred questions about the FDA investigation to the U.S. agency, adding that Pax-All does not manufacture drugs for the Canadian market. “Should any health product manufactured by Pax-All … pose a risk to the health and safety of Canadians, Health Canada will take appropriate actions,” a spokeswoman said in a statement Monday.

The FDA said it found, during an inspection last September, that Pax-All had not cleaned or maintained equipment “at appropriate intervals to prevent contamination that would alter the safety, identify, strength, quality or purity of the drug product … investigators uncovered other deficiencies that lead us to question the effectiveness of your current quality system to achieve overall compliance with [good manufacturing practices] at your facility.”

The agency even cited Pax-All for using duct tape and cardboard to repair its filling lines. “These materials are not suitable materials of construction or easily cleanable, and are not adequate for the manufacture of drug products,” the FDA letter said.

Pax-All is under an “import alert” and can’t ship its products south of the border until it can show the FDA it has complied with all U.S. standards, laws and regulations.

Pax-All vice-president Mario Merino was reluctant to address the FDA letter. “I don’t want to discuss the situation with you now,” he said in an interview. “We’re producing the documents the FDA requested. I want to resolve the issue before we say anything.”

However, he added that “it’s absurd” that the FDA has targeted the company, and said he has to put up with “hassles and inspections” that Asian manufacturers of similar products aren’t subject to. “It’s because we’re close to them. It’s easy for them to inspect us. They don’t go there [to Thailand and China].”

FDA spokeswoman Shelly Burgess said the agency “doesn’t discriminate” in its investigations.

“We just don’t target one company and not others,” she said, adding that the agency 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,” Ms. Burgess said.

There is little public information about Pax-All, which is privately held. On its website, it describes itself as “a Canadian manufacturer of high-quality personal care cosmetics” that specializes in over-the counter products and is registered with the FDA. Mr. Merino said the company has less than $15-million in annual revenue.

This isn’t the first time Pax-All has run afoul of the FDA, according to the agency’s website. In March, 2007, the agency refused entry to the United States of a Pax-All skin formula and foot-care products on grounds they lacked adequate directions or warnings for use and hadn’t received proper regulatory approval. A sister company operating out of the same facility, called Alveeda Inc., was also blocked from exporting a petroleum-jelly product to the U.S. on similar grounds.

The Pax-All sanction is the latest in a string of product issues related to dollar stores, said Rachel Weintraub, director of product safety with the Consumer Federation of America, a Washington-based advocacy group. “We definitely do see concerns consistently popping up about products specifically sold in dollar stores,” she said, citing toxic plush toys, children’s jewellery with high levels of lead and glue guns that cause burns.