Warning letter to Bocchi Laboratories details violations of FDA regulations agency inspectors found in an inspection of firm's facility from late March through early June 2018 "in response to an outbreak of Burkholderia cepacia associated with" a cleanser it manufactures. In addition to product adulteration due to microbial contamination, FDA found Bocchi in violation of drug GMPs because products were labeled with indications rendering them drugs under FDA regulations.
A flying bird and flooding wastewater were among insanitary conditions FDA found at a contract manufacturer that conducted three recalls in 2018 of cleansing foams marketed to health care facilities as well as John Paul Mitchell and other hair care products due to microbial contamination.
A Feb. 6 warning letter to Bocchi Laboratories Inc. details violations of FDA regulations that agency inspectors found in...
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.
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.
This HBW Insight series profiles regulatory affairs specialists working in or supporting the consumer health and beauty product industries. In this installment, we speak to Kenvue's Kevin Whelan.
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.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
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.
