Following an FDA warning letter in 2016 for an unapproved sunscreen drug product, Diamond Wipes now must answer agency concerns regarding “poor-quality water” used in its manufacturing operations. Both warnings stemmed from inspections in the wake of a 2014 product recall for mold contamination.
Contract manufacturer and cosmetic brand owner Diamond Wipes International, Inc. has undergone three inspections and received two warning letters from FDA since it voluntarily recalled an anti-aging eye mask in late 2014 due to contamination.
FDA issued the latest warning March 7, citing the Chino, Calif.-based firm for “significant” violations of current good manufacturing...
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
Global beauty giant is working to adapt its approach to the prestige market to meet escalating competition, increased points of sale, and more knowledgeable consumers with new shopping habits, CFO Tracey Travis said at the Barclays Global Consumer Staples Conference.
Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
Week after publishing safety alert about OPMS Black Liquid Kratom “linked to serious adverse health effects, including death,” FDA announced market research “to understand and characterize emergent risk/safety and perceived benefits reportedly linked to kratom and psychedelics.” But it withdrew the study 10 days later.
Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.
