Supplement GMP Documentation Better, But Still No. 2 On FDA Observation List – AHPA
FDA revisits about a third of supplement manufacturing sites, with two-thirds coming within three years, says AHPA. Chief information analyst Merle Zimmermann says FDA increased focus on recordkeeping has resulted in an improvement and fewer problems reported since 2015
You may also be interested in...
"You end up with a recipe for maybe there's adulterants in the product. Maybe the product wasn't manufactured according to the spec, so it's misbranded. Worse, there could be adulterants. In some of those ingredients, there's a lot of potential failures,” says Patrick Runkle, senior litigation counsel at DoJ Consumer Protection Branch, during FDL conference.
The US Food and Drug Administration directs Marco Pharma International to correct GMP compliance issues identified during a May 2019 site inspection, including quality control and recordkeeping failures, in a warning letter made public 4 February.
Cross Brands violated GMP including verifying the identity of ingredients and made acne- and eczema-treatment label claims for products not covered under the OTC drug monograph, says FDA in a warning letter.