FDA cites Waukesha company
ChemRite uses same equipment to make oral rinse, toxic products, regulators say
Federal regulators have ordered a Waukesha County company to stop making oral hygiene products with the same equipment used to produce car polish that’s labeled “Harmful or fatal if swallowed.”
In a warning letter sent by the U.S. Food and Drug Administration to ChemRite CoPac, of Lannon, the FDA said the company also was making toxic products, such as leather treatments and sealants, with the same mixing tank and product filling line used for overthe-counter oral drug products.
“The ingredients in your non-pharmaceutical products are extremely difficult to remove from manufacturing equipment and could contaminate the drug products that you manufacture on shared equipment, such as the various oral solutions. … It is unacceptable as a matter of (current good manufacturing practices) to continue manufacturing drugs using the same equipment that you use to manufacture toxic industrial-grade car care products,” the FDA said in its June 29 letter.
“In response to this letter, discontinue manufacturing drugs on shared equipment in your facility,” the FDA said.
ChemRite did not return a Journal Sentinel call seeking comment.
The company is a contract manufacturer, meaning it makes products for other companies sold under various names.
“As a private labeler, formulator, blender, tube and bottle filler, ChemRite CoPac specializes in liquids, creams and pastes,” the company says in an employment posting on Milwaukeejobs.com.
Other websites showed that ChemRite has about 175 employees, is privately owned and was founded in 1976.
The FDA letter provided one name of an oral hygiene product made by ChemRite that consumers might recognize
That product was “Sage Perox-A-Mint,” made for Sage Products Inc., a medical products company in Cary, Ill.
In a July 17 warning letter to Sage, the FDA said Perox-A-Mint was “adulterated” for various reasons including the problems at ChemRite.
“Among other things, ChemRite manufactured your oral solution drugs using the same equipment in which ChemRite manufactured toxic industrialgrade car washes and waxes,” the FDA letter to Sage Products said.
The Illinois company did not return a Journal Sentinel call seeking comment, but the FDA said the company’s drugs are often used in hospital or clinical settings in which patients may have a higher vulnerability to infections.
The FDA letter to ChemRite describes a paraffin-based car polish and sealant — labeled “Harmful or fatal if swallowed” and “Keep out of reach of children” — as being made on the same equipment used to make oral hygiene products.
The FDA ordered ChemRite to conduct a risk assessment for all drugs previously produced on equipment shared with industrial products.
“For each product, assess the risk of potential contamination due to the shared equipment, and provide your plans for addressing the product quality and patient safety risks for any product still in distribution, including potential recalls or market withdrawals,” the FDA said.
The agency said it
found “significant violations” of current good manufacturing practices for pharmaceuticals at the plant.
It said the company was not testing its FDA-regulated products adequately and had released at least 24 batches of over-the-counter drugs between 2013 and 2015 “without performing analyses to assess whether they met all microbiological finished-product specifications.”
The FDA also said it found problems in previous inspections at the company in 2013 and 2016.
“You proposed specific remediation for these observations in your responses. These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate,” the June 29 FDA letter said.