Since we last reported on enforcement actions in December 2014,
FDA posted warning letters to canned food processors, seafood
processors, dairies, dietary supplement manufacturers, a pet food
manufacturer, a cosmetics manufacturer, and other food companies
for violations related to CGMP (current good manufacturing
practice), commodity-specific regulations, labeling, illegal drug
residues, and unapproved drug claims, among others.
FDA warned one food manufacturing facility for various CGMP
violations, including packaging food in insanitary conditions and
failure to protect against contamination of food by pests. Five
acidified foods manufacturers, three located overseas, and one a
manufacturer of canned dog and cat food were warned for various
violations of the Acidified Foods and Emergency Permit regulations.
One of these, a sauce manufacturer, was also warned for failing to
declare major food allergens on the label. Seven seafood processing
facilities, including three overseas, were cited for failing to
comply with hazard analysis and critical control points regulations
and for various CGMP violations. Some of the seafood processing
facilities were additionally warned for processing seafood in
insanitary conditions. FDA also warned eight dairy farms for
selling cattle for slaughter adulterated with illegal drug residue.
A juice manufacturer was cited for failing to comply with juice
hazard analysis and critical control points regulations, for CGMP
violations, and for insanitary conditions. Another manufacturer was
warned because its products contained salicylic acid, an unapproved
food additive.
FDA continues to review product labels for incorrect or incomplete
claims. In recent warning letters, the agency cited two
manufacturers for making "healthy" claims on chocolate
products when those products failed to meet the nutrient content
requirements for such claims.
FDA also posted six warning letters to dietary supplement
manufacturers, one located abroad. All six dietary supplement
manufacturers were cited for CGMP violations, and three for
marketing unapproved drugs because their products are promoted for
therapeutic claims. Five of the dietary supplement manufacturers
were also warned for insufficient labels, such as failing to list
capsule ingredients on the label, failing to properly format a
"Supplement Facts" label, failing to label the product as
"dietary supplement," and failing to declare all common
or usual names of each ingredient.
Finally, FDA is increasingly taking enforcement actions in the
area of cosmetics regulation, reflected by an uptick in cosmetics
recalls and warning letters in the last months. Most recently, FDA
warned a skin care products manufacturer that therapeutic claims on
its website—which FDA reviewed following a facility
inspection—rendered the products unapproved new drugs.
View FDA's Warning Letters Homepage (scroll
down for listing of recently posted Warning Letters).
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