Monday, September 19, 2022

FDA Issues Warning Letters to Food Importers for Lack of FSVP

FDA issued a number of Warning Letters to food importers for not having FSVP in place for their imported products.  These are for the first two weeks in September, 2022.

Kuzmir Imports Inc., of  Hillburn, New York was not in compliance with the requirements of 21 CFR part 1, subpart L for the following importee foods: mini soup croutons onion garlic from your foreign supplier (b)(4) located in (b)(4); nougat spread from your foreign supplier (b)(4) located in (b)(4); and cashews from your foreign supplier (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kuzmir-imports-inc-633082-08022022

Mexia Pallets LLC of  San Juan, Texas did not develop, maintain, and follow a FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the imported food products, including each of the following food products:
Persian limes imported from (b)(4), located in (b)(4)
Apple soft drink imported from (b)(4), located in (b)(4)
Orange soft drink imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mexia-pallets-llc-633369-08162022

Visvita Corporation of Santa Fe Springs, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any foods that the company import, including the following foods:
Visvita Chia Drink - Guanabana Flavour imported from (b)(4), located in (b)(4).
Aloe Vera Drink - Pomegranate Flavor imported from (b)(4), located in (b)(4).
Cold Brew Coffee Powder imported from (b)(4), located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/visvita-corporation-633747-08232022

Mercado Hispano Distributors, pf Tucker, GA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the firm did not develop an FSVP for any of the foods they import, including each of the following:
(b)(4) Cola and (b)(4) Manzana imported from (b)(4), located in (b)(4)
(b)(4) Grapefruit imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercado-hispano-distributors-llc-634708-08022022

Mina Global Trading Corp, of  Matawan - "As a very small importer, for each food you import, you did not obtain written assurance in accordance with 21 CFR 1.512(b)(3), before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act"
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mina-global-trading-corp-636140-08082022

Bharat Ratan LLC. of  Renton, WA id not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically. the company did not develop, maintain, and follow an FSVP for any of the foods imported, including:
Fenugreek leaves, Gur Rewri (Sesame Brittle), and Punjabi Biscuit, imported from (b)(4), located in (b)(4)
Meat Masala (Curry Spice Mix) imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bharat-ratan-llc-634674-08222022

BLUE STONE IMPORT USA INC of Manhasset, NY did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop an FSVP for any of the food products imported, including each of the following foods:
(b)(4) Spicy Chicken Flavor Ramen ((b)(4)) from (b)(4), located in (b)(4)
Wheat Flour from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blue-stone-import-usa-inc-636668-08032022

Jones Affiliated IncCerritos, CA did not develop an FSVP for any of the foods  imported, including:
Wild Yam Flavor Powder, imported from (b)(4) located in (b)(4)
Premium White Gourd Jam, imported from (b)(4) located in (b)(4)
Red Bean Paste, imported from (b)(4) located in (b)(4)
Black Sesame Powder, imported from (b)(4) located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jones-affiliated-inc-639035-0823202

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