Altaire "is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility," firm says in its recall announcements.
Concerns that insufficient manufacturing quality controls could render its ophthalmic products non-sterile prompted Altaire Pharmaceuticals Inc. to recall nearly 270 lots of store-brand OTCs sold by CVS Health Corp., [Wal-Mart Stores Inc.] and Walgreen Co..
In its latest announcement about the recalls, concerning CVS Health products, Altaire said the US Food and Drug Administration "has...
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.
As it has every year since FSMA was passed in 2011, FDA doesn’t plan to impose reinspection fees until it publishes guidance for small businesses to request reductions. FY2025 budget proposal includes plan “to re-structure the fee programs to make it more administratively feasible to operate.”
Senate majority whip asks four supplement industry trade groups for “a written plan to work with responsible supplement manufacturers to remove tianeptine and other dangerous or illegal ingredients from the supplement market.”
Nearly 1,300 rodents exterminated at Arkansas warehouse after FDA investigation found lack of climate control in store of food and OTC drugs requiring dry, room-temperature conditions. Firm pleads guilty in largest monetary criminal penalty in US food safety case.
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.
In this installment of HBW Insight’s “Inside Regulatory Affairs” series, we hear from Sharee Crumbey and Monica Sharda, regulatory affairs specialists at The Honest Company, about the mounting challenges and rewards of the job.
