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WARNING LETTER
•MVS Richardson, LLC d/b/a Metro Vapors Burleson•June 4, 2020

FDA WARNING_LETTER - MVS Richardson, LLC d/b/a Metro Vapors Burleson - June 04, 2020

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Record Details

This FDA Warning Letter, dated June 4, 2020, addresses MVS Richardson, LLC d/b/a Metro Vapors Burleson, regarding violations concerning their e-liquid products, specifically "Thousand Sunny e-liquid." The FDA determined these products are tobacco products under the FD&C Act.

The identified violations include: 1. **Misbranded Product Listing:** The "Thousand Sunny e-liquid" product is not included in a list required by section 905(i) of the FD&C Act (21 U.S.C. § 387e(i)), making it misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)). Failure to provide this information is a prohibited act under section 301(p) (21 U.S.C. § 331(p)). 2. **Misbranded Due to Missing Ingredient Listing:** The company failed to provide an ingredient listing as required by section 904(a)(1) of the FD&C Act (21 U.S.C. § 387d(a)(1)). This renders the "Thousand Sunny e-liquid" misbranded under section 903(a)(10)(A) (21 U.S.C.

Company
MVS Richardson, LLC d/b/a Metro Vapors Burleson
Inspection Date
June 4, 2020
Product Type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
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ID · 3ee092e1-f991-494d-8369-d3bce75cf567

Violation Codes10
21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 CFR 1100.121 U.S.C. 387e(i)21 U.S.C. 387e(i)(3)(A)21 U.S.C. 387c(a)(6)21 U.S.C. 331(k)21 U.S.C. 331(p)21 U.S.C. 387d(a)(1)21 U.S.C. 387c(a)(10)(A)

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