GMP Documentation, Identity Testing Continue To Trip Supplement Firms
This article was originally published in The Tan Sheet
Warnings from FDA's Office of Regulatory Affairs make clear that failing to document compliance with each GMP requirement renders those parts of the process noncompliant. Warning letters posted March 22 also include FDA's latest enforcement against firms marketing bulk caffeine.
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FDA warns own-labelers ProSupps USA and Cape Fear Naturals about GMP violations, also pointing out ProSupps dropped the ball on submitting serious AERs to FDA and Cape Fear Naturals made drug claims including “improve blood pressure and cholesterol.”
FDA's latest supplement GMP warnings once again demonstrate the importance of appropriate documentation during manufacturing and in responding to questions from agency inspectors.
Serving amounts such as one-sixteenth of a teaspoon indicated on product labels “cannot be accurately measured using common household measuring tools,” FDA says. NPA, however, suggests the agency gives too little credit to consumers’ measuring skills.