FDA Issues Warning Letters to Eight Different Food Importers for FSVP Noncompliance

Over the past 2 weeks, FDA has issued 8 Warning Letters to food importer for non-compliance with the Foreign Supplier Verification Program (FSVP).  In all cases, programs were just not in place for food items that were being imported.  Some of these companies had received prior inspection where they were informed that they needed to have a FSVP in place.

Global Imports Inc. of Kingwood, TX 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, you did not develop an FSVP for any of the food products you import, including:
• Chopped Spinach imported from foreign supplier (b)(4), located in (b)(4)
• Cut Cauliflower imported from foreign suppliers (b)(4), and (b)(4), located in (b)(4)
• Cut Corn imported from foreign supplier (b)(4), located in (b)(4)
• Diced Yellow Peaches imported from foreign supplier (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-imports-inc-626682-04072022

Bhan Kanom Thai Inc of Los Angeles, CA you did not develop, maintain, and follow an FSVP for any of the products you import including each of the following food products:
Cookie Rolls - Herbal imported from (b)(4)
(b)(4) Chip imported from (b)(4)
(b)(4) Dipping Sauce imported from (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bhan-kanom-thai-inc-625822-03282022

Madras Groceries of Sunnyvale, 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, you did not develop, maintain, and follow an FSVP for any of the foods that you import, including:
Snack - Butter Murukku - imported from (b)(4) in (b)(4)
Snack - Banana Chips - imported from (b)(4) in (b)(4)
Snack - (b)(4) - imported from (b)(4) in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madras-groceries-626403-03282022

SCO Koladen LLC of Livermore, 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, you did not develop, maintain, and follow an FSVP for any of the foods you import, including:
• (b)(4) Milk Chocolate with Almonds imported from (b)(4), located in (b)(4)
• (b)(4) imported from (b)(4), located in (b)(4)
• Advent Calendar with chocolate pieces imported from (b)(4), located in (b)(4)
During our inspection you provided three documents which you obtained from your foreign suppliers: a “FSMA” document for (b)(4); an Audit Report for (b)(4); and a Food Safety Plan for (b)(4). However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sco-koladen-llc-629661-04142022

Best Fiji Kava, Inc.of Hayward, CA 94544 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, you did not develop an FSVP for any of the foods you import, including each of the following food products imported from (b)(4) located in (b)(4):
(b)(4) Crackers
Snack Chips
(b)(4) Noodles
We acknowledge that during the most recent inspection, you told our investigator that you intended to retain a consultant within 30 days of our inspection to help develop your firm’s FSVPs. As of the date of this letter, we have not received any information regarding your FSVPs or planned corrective actions..

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/best-fiji-kava-inc-623296-02162022

Don’t Run Out dba Public Goods of New York, NY did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for (b)(4) Ramen Noodles) from (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dont-run-out-dba-public-goods-626847-03112022

7333 LLC of Lakewood, Washington 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, you did not develop an FSVP for any of the foods you import, including:
(b)(4) Scorched Barley imported from (b)(4)
Frozen Dumpling imported from (b)(4)
Macaroni imported from (b)(4)
Rice Noodle Soup imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/7333-llc-625974-04132022

Alymar LLC of  Houston, Texas 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). Specifically, you did not develop an FSVP for any foods you import, including the following:
Cola soft drinks imported from (b)(4), located in (b)(4)
Potato chips imported from (b)(4), located in (b)(4)
Corn chips imported from (b)(4), located in (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alymar-llc-626418-04122022