Food firms warned over lack of Foreign Supplier Verification Programs

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

---

Grace Supply Inc.
Missouri City, TX

An import company in Texas is on notice from the FDA for not having FSVPs for several imported food products.

In a Jan. 8 warning letter, the FDA described Aug. 16 and Sept. 6, 2023, Foreign Supplier Verification Program (FSVP) inspections of Grace Supply Inc.. in Missouri City, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. 

Some of the significant violations are as follows:

1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any foods that they import, except for the following foods:

• Extra hot snack mix imported from (redacted by FDA), (redacted by FDA)
• Shredded frozen coconut imported from (redacted by FDA), (redacted by FDA)
• Banana chips imported from (redacted by FDA) and (redacted by FDA), (redacted by FDA)

While they provided FSVP documents for extra hot snack mix imported from (redacted by FDA), located in (redacted by FDA) and shredded frozen coconut from (redacted by FDA), located in (redacted by FDA), these documents do not meet the FSVP requirements, as discussed below.

2. The firm’s hazard analysis for the shredded frozen coconut from (redacted by FDA), located in (redacted by FDA), did not identify and evaluate coconut as a potential chemical hazard (food allergen) to determine whether the hazard requires a control. A hazard analysis must identify known or reasonably foreseeable hazards for each type of food they import to determine whether there are any hazards requiring a control. The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including pesticide residues), and physical hazards. Specifically, coconut is a tree nut and is recognized by FDA as a food allergen. Their hazard analysis for shredded frozen coconut and the hazard analysis provided by their foreign supplier did not identify and evaluate coconut as a potential chemical hazard.

3. The firm did not meet the requirements to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed for each foreign supplier before importing the food and periodically thereafter. The firm’s FSVP for the extra hot snack mix imported from (redacted by FDA), located in (redacted by FDA), documented that they determined “a combination of sampling and testing and review of relevant food safety records is the appropriate verification activity” with a frequency of “quarterly until a history is established and annually thereafter.” However, they did not conduct and document (or obtain documentation of) one or more such supplier verification activities for their foreign supplier. The firm FSVP included a copy of a self-assessment audit report for the extra hot snack mix imported from (redacted by FDA), however, the audit was conducted at their supplier’s parent company, (redacted by FDA), not their supplier (redacted by FDA). Further, they did not document or provide records of any sampling and testing results. Therefore, they did not conduct and document or obtain documentation of one or more supplier verification activities before importing their extra hot snack mix imported from (redacted by FDA) into the United States, as required.

4. The firm’s supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods they import have been significantly minimized or prevented, as required. Specifically, they determined that for their shredded frozen coconut from (redacted by FDA), 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).

The full warning letter can be viewed here.

Mexpobaja Corporation
Oakland, CA

An import company in California is on notice from the FDA for not having FSVPs for several imported food products.

In a Jan 23 warning letter, the FDA described an Aug. 29-31, 2023, Foreign Supplier Verification Program (FSVP) inspection of Mexpobaja Corporation in Oakland, CA.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. 

Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods from the foreign suppliers below:

• Pitahaya (Dragonfruit), imported from (redacted by FDA), located in (redacted by FDA)
• Pasilla Chili Peppers (Poblano), imported from (redacted by FDA), located in (redacted by FDA)
• Jalapeno Peppers imported from (redacted by FDA), located in (redacted by FDA)

The full warning letter can be viewed here.

A True Move LLC
Houston, TX

An import company in Texas is on notice from the FDA for not having FSVPs for several imported food products.

In a Dec. 18, 2023 warning letter, the FDA described an Oct. 12-13, 2023, Foreign Supplier Verification Program (FSVP) inspection of A True Move LLC in Houston, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. 

Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods from the foreign suppliers below:

• Banana Sodas imported from (redacted by FDA), located in (redacted by FDA)
• Lollipops imported from (redacted by FDA), located in (redacted by FDA)
• Tomato Paste imported from (redacted by FDA), located in (redacted by FDA)

The full warning letter can be viewed here.

JJR Global Inc.
Missouri City, TX

An import company in Texas is on notice from the FDA for not having FSVPs for several imported food products.

In a Dec. 1, 2023 warning letter, the FDA described an Aug. 9-10, 2023, Foreign Supplier Verification Program (FSVP) inspection of JJR Global Inc. in Missouri, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. 

Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods from the foreign suppliers below:

• (redacted by FDA), Sweet Mango Chutney, and Coriander Chutney (Frozen) from (redacted by FDA) located in (redacted by FDA)

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here.)