Issues arose after a January inspection
Skincare company Triderma isn't testing its products enough to ensure they are safe, the U.S. Food and Drug Administration said Tuesday.
The FDA inspectedTriderma's factory in Anaheim, Calif.,in January, finding the company wasn't properly testing raw materials, such as salicylic acid, allantoin and colloidal oatmeal for various skincare products, including for eczema and diabetics.
In particular, Triderma wasn't testing each shipment of glycerin, which is at high risk of having unsafe levels of the hazardous impuritiesdiethylene glycol (DEG) or ethylene glycol (EG), the FDA said in its warning letter. Ingredients contaminated with DEG or EG have lethally poisoned people.
The FDA also said Triderma wasn't validating its manufacturing process andwasn't testing enough to ensure productsare stored correctly under expiration dates.
Not pleased with the response
Triderma's response has been inadequate, the FDA said. The company didn't provide enough details committing to testing each lot of incoming raw materials and the quality of products that are within expiration, among other issues.
"We are aware of the recent publication [of the FDA's letter] and have taken steps to resolve this matter aggressively and adequately in its entirety with the FDA, which remains in progress currently," Triderma President Holly Ahearn told ConsumerAffairs.
"Further updates will be forthcoming to our esteemed partners and valued customers, and we look forward to achieving the formal Close Out notice for this regulatory action very soon," she added.
Photo Credit: Consumer Affairs News Department Images
Posted: 2024-07-24 11:01:53
