Custompax Inc. needs FDA's approval before it can again make dietary supplements for e-ommerce sites that provide custom products after failing on multiple chances since 2011 to correct its good manufacturing practices problems.
Custom Supplement Firm Shut Down: Health And Wellness Industry News
Warning letter and multiple form 483s fail to convince Custompax; Kellogg acquires RXBAR clean-label protein bars for $600m; NutraFuels used Blast Cap for products; and more news in brief.
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The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
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US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.
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Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.