Environmental Issues
Due to both sanitation and environmental pathogenic contamination concerns, a manufacturer of RTE soft tortillas received an FDA warning letter citing sanitation SOP deviations, including
Category: FDA Warning Letters
Warning letter includes lack of mycotoxin hazard analysis
The lack of identification and evaluation of mycotoxins as a potential hazard and incomplete implementation of supply chain controls comprised just one area of the
Soy Protein
After an inspection of an RTE soy protein isolate manufacturing facility, FDA issued a 483, then a warning letter due to observations and continuing concerns
Acidic Foods Manufacturer Warned for Noncompliance
A manufacturer of acidified foods was found to be in violation of the Acidified Foods regulations because they did not fully comply with registration and
Sprout Farm Warned for Not Correcting Violations
An FDA Warning Letter was issued to a sprouting operation after inspection observations found a number of serious violations that remained uncorrected. Of high concern
Accurate Allergen Labeling is Critical
Accurate labeling of products is critical in the food industry, particularly when allergens are involved. As shown by a recent warning letter to a Hawaiian
Restaurant Meals Manufacturer Cited
Following a 2023 inspection of a restaurant RTE meals manufacturer, the FDA issued the facility a warning letter due to continued concerns with the noted
Sprout and Kimchi Operation Receives Warning Letter
In a 2023 inspection, FDA determined that the soybean sprouts grown in a sprout and kimchi operation were adulterated as they were prepared, packed, or
Processor Cited for Seafood HACCP Violations
The failure of a seafood processor to have and implement a seafood HACCP plan can constitute a serious regulatory violation. It was exactly that for
Undeclared Nuts Lead to Warning Letter
After three recalls of nut-containing products from a Michigan-based distributor within six weeks, the FDA issued a warning letter. The finding noted that food allergen
