OTC Topicals After Bite, Itch Eraser Are Irritants To US FDA Monograph, GMP Regulations
Adventure Ready Brands is the second small firm warned recently by FDA about manufacturing and marketing products labeled as nonprescription drugs but noncompliant with relevant OTC drug monographs and about GMP violations.
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Eosera has removed its Ear Pain MD and Ear Itch MD products from e-commerce pages on its website following FDA's warning letter. The warning identifying the pain and itch products as unapproved new drugs also states that a January inspection of the firm’s facility found GMP violations.
While FDA continues posting announcements of recalls of hand sanitizers made by firms in Mexico and found to contain methanol, its latest recall records update also show Michigan Herbal Remedies recalled a total of 5,938 bottles of hemp oils due to elevated lead levels.
Final rule amends FDA regulation on gluten-free labeling to provide alternative means for the agency to verify compliance. It will determine whether a firm is compliant from records it must maintain, and make available for inspection and copying, of the fermented or hydrolyzed supplements and food products bearing the claim.