Food Importers Cited for Not Having FSVP - Jan-Feb 2023 Edition

FDA issued Warning Letter to the following food importers for not having a FSVP in place for their imported foods.

Sohgave LLC of Houston, TX did not develop, maintain, and follow an FSVP for any imported foods including Honey from one foreign company and Agave Syrup, honey, coconut syrup and inulin syrup imported from another.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sohgave-llc-646874-01192023

AMO and Wing Inc. dba T and H Trading Co. of Oakland, CA - as "a very small importer is must 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. Specifically, you did not provide written assurances from your foreign suppliers for any of the foods you import, including dried noodle and dried bean curd from (b)(4); and vermicelli from (b)(4)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amo-and-wing-inc-dba-t-and-h-trading-co-638293-12072022

HST Produce, Inc. of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, the firm did not develop, maintain, and follow an FSVP for any of their imported foods including each of the following foods:
Fresh prickly pear imported from (b)(4), Fresh jalapeno pepper imported from (b)(4), Peruano beans imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hst-produce-inc-639794-11072022

S&S Quality Wholesale Inc. of El Cajon, CA did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). for any of thier imported foods including:  Bashan Koftelik Bulgur Fine imported from (b)(4), located in (b)(4), Bread Sticks imported from (b)(4), located in (b)(4),Wheat Kernal Habiya imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ss-quality-wholesale-inc-630772-06012022

Leimax, Corp of Yonkers, NY did not develop an FSVP for any of the their imported foods including each of the following foods: Lollipops ((b)(4)) manufactured by (b)(4). Cola flavored soft drink manufactured by (b)(4). (b)(4) hot sauce manufactured by (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leimax-corp-633364-10072022

Fuentes Farms LLC of McAllen, TX 7 did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).for any of their imported foods including: green onions imported from foreign supplier (b)(4) chayote imported from foreign supplier (b)(4)
broccoli imported from foreign supplier (b)(4)

"You import fresh produce, that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates that your 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 419 of the FD&C Act (21 U.S.C. § 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112)."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fuentes-farms-llc-642138-10142022

TL State Management of Brooklyn, NY did not develop an FSVP for any of their imported  food products including Pickled red tomatoes from (b)(4)  Puff pastry dough from (b)(4) and (b)(4) wafers from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tl-state-management-inc-634663-08302022

San-Rey Produce Inc.of Pharr, Texas. did not develop an FSVP for any of their imported foods including:  onions imported from foreign supplier, (b)(4), (b)(4) limes imported from foreign supplier, (b)(4) and coriander imported from foreign supplier,
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/san-rey-produce-inc-643593-12072022