A contract manufacturer in Wisconsin has received a warning letter from the FDA regarding some potentially weird cross-contamination.
The company, ChemRite CoPac, says on its website that it’s regularly contracted to “blend and pack liquids, creams, lotions and pastes for a variety of markets.” According the Milwaukee Journal Sentinel, ChemRite CoPac is being accused by the FDA of using the same equipment for making an oral hygiene product as it does for making car polish that's labeled “Harmful or fatal if swallowed.”
The letter from the FDA accuses the company of also processing other toxic non-pharmaceutical industrial and automotive care products, such as leather treatments and sealants, with the same equipment that process oral solutions like mouth rinses and moisturizing products. It goes on to say that the specific ingredients being used in the non-pharmaceutical grade products are “extremely difficult to remove from manufacturing equipment.”
Only one oral rinse was called out by name in the letter -- “Sage Perox-A-Mint,” made for an IL-based medical products company called Sage Products. The Journal Sentinel report cites the FDA when it says that Sage’s products are “often used in hospital or clinical settings in which patients may have a higher vulnerability to infections.”
And based on the overall tone and content of the FDA letter, this isn’t ChemRite’s first brush with bad manufacturing practices. The federal agency says that previous inspections in both 2013 and 2016 yielded similar observations, and that ChemRite’s proposed remediation had failed.
I’m Anna Wells and this is IEN Now.
