FDA Warns Gilchrist & Soames Following Massive Contamination Recall
This article was originally published in The Rose Sheet
G&S, which manufactures personal-care products for hotels and spas worldwide, recalled more than 2 million potentially contaminated units of bath and body products last year, but its regulatory compliance issues are not behind it yet. In a March 16 warning letter, FDA cites the firm for inspection failings and product sample analyses that render its products adulterated under US cosmetics law.
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The companies initiated voluntary recalls in May after finding evidence of microbial contamination – in Arbonne’s case, the presence of Pluralibacter gergoviae in a body wash product, and in BECCA’s, “a brownish-black material identified as a common household mold” identified on a makeup applicator.
Around 96% of warning letters for excessive cosmetics claims in 2016 have issued from FDA district offices as opposed to CFSAN headquarters, representing a marked shift from previous years. The agency stresses, however, that the source of a warning letter has no bearing on its implications.
Cosmetic firms already are being closely watched by FDA for overreaching product claims, but if formal good manufacturing practices are established for the sector down the road under regulatory reform legislation, companies could be targeted increasingly with warning letters like that issued to Beauty & Health International for quality-control violations at its Garden Grove, California facility.