Food firms in Texas and California warned over import violations

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. The FDA frequently redacts parts of warning letters posted for public view.

Jaramillo Spices Corp.
McAllen, TX

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

In a June 8 warning letter, the FDA described a March 26 through April 9, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Jaramillo Spices Corp in McAllen, 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. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop, maintain, and follow an FSVP for any of the food products they import, including the following foods:

• Fresh tamarind imported from (redacted)
• Black beans imported from (redacted)
• Vanilla flavoring imported from (redacted)

The full warning letter can be viewed here.

Daisy Global Trading Co.
Cerritos, CA

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

In an April 15 warning letter, the FDA described a Nov. 18 through Dec. 4, 2020, remote Foreign Supplier Verification Program (FSVP) inspection of Daisy Global Trading Co. in Cerritos, 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.

The FDA acknowledged receipt of the firm’s response, dated Dec. 29, 2020, in which they provided their written procedure regarding FSVPs for their imported products. Enclosed were six FSVPs for the following foods: frozen oriental style udon, fresh Japanese style udon, roasted seasoned seaweed (Laver), Buckwheat noodle (Zaru Soba), scorched rice, and Korean biscuit (Rice stick). During the inspection, the firm also provided their FSVP Manual that addressed the documents required from their foreign suppliers: Supplier Letter of Guarantee, Supplier Approval Questionnaire, Hazard Analysis and Critical Control Points (HACCP) Plan, Liability Insurance, and Certificate of 3rd Party Audit. The firm’s FSVP manual also listed the documents their firm must complete and verify for their foreign suppliers: Foreign Supplier Verification Activity Worksheet, FSVP Food Hazard Analysis Form, FSVP Foreign Supplier Evaluation Form, FSVP Supplier Re-evaluation Form, and FSVP Supplier List for Daisy Global Trading. FDA review of their response finds that they have not addressed all the violations related to the food products they import, as further described in this letter.

The significant violations are as follows:

1. The firm did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter as required. The firm’s Dec. 29, 2020 response included six documents titled “FSVP-Foreign Supplier Evaluation.” They did not conduct and document or obtain documentation of one or more supplier verification activities before importing rice sticks imported from (redacted); scorched rice imported from (redacted); Buckwheat noodle (Zaru soba) imported from (redacted); and Korean seasoned seaweed imported from (redacted), all located in (redacted). The firm also did not provide their documentation of the frequency with which the verification activity will be conducted.
2. The firm did not provide their documentation of the corrective action implementation. In their Dec. 29, 2020 response, their document titled “FSVP-Foreign Supplier Evaluation” for their rice stick imported from (redacted) includes a description under “corrective action needed” of “HACCP Plan, HA & PC, Allergen control Program Required.” Further, their hazard analysis identified allergens as a chemical hazard with justification stated as the product is processed in a facility that also processes peanut, egg, fish, tree nut, wheat, milk, and soybean. However, they have not verified that the supplier has an allergen control program in place. The firm did not document their corrective action implementation.

The full warning letter can be viewed here.

Mr Lukas LLC
McAllen, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In an April 9 warning letter, the FDA described a Jan. 25-28, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Mr Lukas LLC in McAllen, 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. The significant violations are as follows:

The firm did not develop FSVPs as required. Specifically, the firm did not develop FSVPs for the foods they import from (redacted), including but not limited to canned nacho sliced jalapenos, Mexican style hominy, and tomato tomatillo.

The FDA acknowledges that the firm informed FDA investigators during the inspection that they (redacted). The firm also stated they would notify their foreign supplier and their U.S. Customs Broker to (redacted). To date, we have not received a written commitment from them that (redacted), FDA records show they continue to import foods. Please note, as long as they continue to import covered foods into the United States and they meet the definition of an importer as defined in section 805(a)(2) of the FD&C Act and 21 CFR 1.500, they are the FSVP importer and they are required to comply with FSVP requirements.

During the FDA’s most recent inspection they acknowledged the firm provided information to demonstrate they may (redacted), and may choose to (redacted). However, they have not (redacted). Regardless of (redacted), they are still required to follow FSVP requirements. If the firm chooses to (redacted), the firm must document that they (redacted), (redacted).

The full warning letter can be viewed here.

Tuty Usa LLC
Conroe, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a June 9 warning letter, the FDA described a March 26 through April 14, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Tuty USA LLC in McAllen, 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. The significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop, maintain, and follow an FSVP for any of the food products they import, including but not limited to their wheat snacks and Japanese peanuts imported from (redacted) and Blackberry Tartlet Cookies imported from (redacted).

On April 2, 2021, the firm emailed FDA investigator certificates of analysis for “Japanese Style Peanut” and “Snacks Tuty,” a food defense plan for (redacted) and a (redacted) for (redacted). The firm did not provide an explanation of these documents, describe how they would apply to their FSVP program, state that they constitute their FSVP program, or provide a record of their review of these documents. These documents alone do not constitute an FSVP.

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, the firm is responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.

The full warning letter can be viewed here.

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