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WARNING LETTER
•Tabatchnick Fine Foods, Inc.•June 17, 2010

Tabatchnick Fine Foods, Inc. – FDA Warning Letter, Jun 17, 2010

Record Details

On June 17, 2010, an FDA investigator collected a sample of Tabatchnick Fine Foods, Inc.'s Frozen Barley and Mushroom Soup. Analysis revealed the product is misbranded under the Federal Food, Drug, and Cosmetic Act.

Firstly, the product is misbranded because its label is false or misleading. The label declares 40 mg of sodium per serving, but FDA analysis found 205.4 mg (original) and 227.7 mg (check), exceeding the declared value by 414% and 469% respectively, violating 21 CFR 101.9(g)(5).

Secondly, the product is misbranded because it bears an unauthorized nutrient content claim. The label states "LOW SODIUM," which is a nutrient content claim. However, the product's sodium content (at least 205.4 mg per 213g serving) exceeds the 140 mg per Reference Amount Customarily Consumed (RACC) limit for "low sodium" claims (21 CFR 101.61(b)(4)), misbranding it under Section 403(r)(1)(A) of the Act.

The FDA also noted the "No Salt – No Sugar Added" claim, advising compliance with 21 CFR 101.61(c) and 21 CFR 101

Company
Tabatchnick Fine Foods, Inc.
Inspection date
June 17, 2010
Office
New Jersey District Office
Person
  • Diana Amador-Toro (District Director)
View Company Profile

ID · cf5a7c2a-4ca8-4221-bdcc-5816f5fee606

Violation Codes9
21 CFR 10121 U.S.C. 343(a)(1)21 CFR 101.9(g)(5)21 U.S.C. 343(r)(1)(A)21 CFR 101.13(b)21 CFR 101.61(b)(4)21 CFR 101.12(b)21 CFR 101.61(c)21 CFR 101.60(c)(2)

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