US Food Drug Administration bans Canadian health care items on QC issue
2012 04 09
- Details
A TORONTO area company's deodorants, chest rubs, petroleum jellies, soaps and cosmetics have been banned in the US by the Food and Drug Administration (FDA) from shipping products to dollar stores until it meets acceptable quality control standards.
The FDA accused Pax-All Manufacturing of failing to perform acceptable testing, labelling or documenting, and having no testing programme to assess proper storage or expiry dates, reported the Toronto Globe and Mail.
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 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 export products to the US until it can show the FDA it has complied with its standards.
Pax-All vice-president Mario Merino said "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]."
Mr Merino said the company has less than US$15 million in annual revenue.
Said Consumer Federation of America director Rachel Weintraub: "We see concerns popping up about products in dollar stores."
Source Shipping Gazette - Daily Shipping News
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