FDA Warning Letters Issued to Food Importer for FSVP - Jan/Feb 2024 Edition

FDA issued Warning Letters to several food importers.  While three of the five were the same old thing, no FSVP for importer food, the other two had FSVP programs (for some items) but these programs were improperly designed and/or implemented.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indian-groceries-and-spices-inc-663853-10182023
Indian Groceries and Spices, Inc.  Chicago, IL 
Did not have an FSVP for any of the foods you import, including the following foods:

• Whole Cumin Seeds manufactured by (b)(4)
• Extra Hot Chili Powder manufactured by (b)(4)
• Green Mung Bean (Split Huskless) manufactured by (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jjr-global-inc-665855-12012023
JJR Global Inc., Stafford, TX
did not develop an FSVP for any of the foods you import, including the following foods:
(b)(4), Sweet Mango Chutney, and Coriander Chutney (Frozen) from (b)(4) located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/true-move-llc-670651-12182023
A True Move LLC  Houston, TX
Did not develop an FSVP for any of the foods you import, including the following foods:

• Banana Sodas imported from (b)(4), located in (b)(4)
• Lollipops imported from (b)(4), located in (b)(4)
• Tomato Paste imported from (b)(4), located in (b)(4)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grace-supply-inc-668552-01082024
Grace Supply Inc.,  Missouri City, TX
Did not develop an FSVP for any foods that you import, except for the following foods:

• Extra hot snack mix imported from (b)(4), (b)(4)
• Shredded frozen coconut imported from (b)(4), (b)(4)
• Banana chips imported from (b)(4) and (b)(4), (b)(4)

While you provided FSVP documents for extra hot snack mix imported from (b)(4), located in (b)(4) and shredded frozen coconut from (b)(4), located in (b)(4), these documents do not meet the FSVP requirements, 

Shredded frozen coconut

• Did not identify and evaluate coconut as a potential chemical hazard (food allergen)
• Determined that for shredded frozen coconut from (b)(4), there is a hazard, specifically Salmonella, that will be controlled by the foreign supplier. Salmonella is a hazard that results in serious adverse health consequences or death to humans or animals (SAHCODHA).1 In accordance with 21 CFR 1.506(d)(2), when a hazard in a food will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you must conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless you make an adequate written determination that, instead of such initial and annual onsite auditing, other supplier verification activities listed under 21 CFR 1.506(d)(1)(ii) and/or less frequent onsite auditing are appropriate to provide adequate assurances that the foreign supplier is producing the food in accordance with 21 CFR 1.506(c), based on the determination made under § 1.505. Based on a review of your FSVP documents for shredded frozen coconut from (b)(4), you did not conduct and document or obtain documentation of an onsite audit of the foreign supplier at least annually after importing the food into the United States. Although you provided documentation of an FDA on-site inspection conducted January 31, 2019, of (b)(4), located in (b)(4), it was not conducted before initially importing the food and at least annually thereafter.

Extra hot snack mix

• Your FSVP included a copy of a self-assessment audit report for the extra hot snack mix imported from (b)(4), however the audit was conducted at your supplier’s parent company, (b)(4), not your supplier (b)(4). Further, you did not document or provide records of any sampling and testing results. Therefore, you did not conduct and document or obtain documentation of one or more supplier verification activities before importing your extra hot snack mix imported from (b)(4) into the United States, as required per 21 CFR 1.506(e)(1).

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mexpobaja-corporation-670016-01232024
Mexpobaja Corporation Oakland, CA
Did provide FSVP documents for the following foods...however....
Pitahaya (Dragonfruit), imported from (b)(4), located in (b)(4)
Pasilla Chili Peppers (Poblano), imported from (b)(4), located in (b)(4)
Jalapeno Peppers imported from (b)(4), located in (b)(4)

• While you provided our investigator a variety of FSVP documents for these specific foods, including the firm’s written procedures for evaluating and approving foreign suppliers and a food safety questionnaire for foreign suppliers, these documents do not meet the FSVP requirements, as discussed below.
• Supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). Specifically, your FSVPs for Pitahaya (Dragonfruit), from (b)(4), Pasilla Peppers (Poblano), from (b)(4), and Jalapeno Peppers, from (b)(4) include “Table D4”, “Table C4”, and “Table B4” respectively. Each of these three tables includes the column labeled “Description of Supplier Controls” under which the specific supplier controls are described as “On-site Audit of the packinghouse facilities” and “Letter of Continuing Guarantee and food safety questionnaire.” The tables indicate these verification activities are conducted with a frequency of “Annually.” Based on your description of these records to our investigator, “Table D4", “Table C4”, and “Table B4” in their respective FSVPs, describe your verification activities. The records you provided to demonstrate your verification activities for these foods and suppliers include:
• Letter of Continuing Guarantee
• Food Safety Questionnaire for Foreign Suppliers (which are not in English)
• Chemical analysis results for Pasilla Chili Pepper (Poblano) from (b)(4), and Pitahaya (Dragonfruit) from (b)(4)
• Chemical and microbiological analysis results for Jalapeno Peppers from (b)(4) (which are not in English)
• These records do not indicate whether you verified your supplier’s compliance with the Produce Safety Rule. In addition, you did not demonstrate the standards on which the letters of guarantee or food safety questionnaire, or onsite audits, which you did not provide record of, provide at least the same level of public health protection provided by the Produce Safety Rule.
• Pitahaya (Dragonfruit), Pasilla Peppers (Poblano), Jalapeno Peppers, and other fresh produce that you import are “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).