Since we last reported on enforcement actions in April 2015, FDA
posted warning letters to seafood processors, dairies, and other
food companies for violations related to CGMP (current good
manufacturing practice), commodity-specific regulations, labeling,
illegal drug residues, unapproved drug claims, and cosmetics, among
others.
FDA warned four seafood processing facilities for failing to
comply with hazard analysis and critical control points
regulations, for various CGMP violations, and for processing
seafood in insanitary conditions. One bakery was warned for various
CGMP violations, including failure to follow hygienic practices and
failure to exclude pests from processing areas. An animal food
manufacturer was warned for adding an unapproved food additive to
its feed. FDA also warned nine dairy farms for selling cattle
adulterated with illegal drug residue for slaughter.
FDA continues to review product labels for incorrect or incomplete
claims. FDA cited a snack bar manufacturer and an organic pop maker
for improperly labeling their products as "healthy" when
the product does meet the requirements to make the nutrient content
claim.
FDA ramped up its enforcement of dietary supplement manufacturers
since our April 2015 issue. Five manufacturers were warned because
their products contained Beta-methylphenethylamine, which is not a
dietary ingredient, nor is it approved as a food additive. An
additional 14 manufacturers were warned because their products
contained 1,3-Dimethylbutylamine, which has not been approved as a
dietary ingredient. One dietary supplement manufacturer was warned
for various CGMP violations and for marketing unapproved drugs
because its product is promoted for therapeutic claims.
Finally, in a rare warning letter to a cosmetics manufacturer, FDA
warned a manufacturer of eye shadow products because the products
contained the ocular pathogen Bacillus cereus and for
manufacturing the cosmetics in insanitary conditions.
View FDA's Warning Letters Home
page (scroll down for listing of recently posted Warning
Letters).
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