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.

AMO and Wing Inc. dba T and H Trading Co.
Oakland, CA

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

In a Dec. 7, 2022, warning letter, the FDA described a June 21 and 22, 2022, Foreign Supplier Verification Program (FSVP) inspection of AMO and Wing Inc. dba T and H Trading Co. 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:

As a very small importer, for each food the firm imports, they must obtain written assurance, before importing the food and at least every two years thereafter, that their 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, 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, the firm did not provide written assurances from their foreign suppliers for any of the foods they import, including dried noodle and dried bean curd from (redacted); and vermicelli from (redacted).

The full warning letter can be viewed here.

HST Produce Inc.
Houston, 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 Nov. 7, 2022, warning letter, the FDA described a June 23 – July 7, 2022, Foreign Supplier Verification Program (FSVP) inspection of HST Produce 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. Specifically, they did not develop an FSVP for each of the following foods:

• Fresh prickly pear imported from (redacted)
• Fresh jalapeno pepper imported from (redacted)
• Peruano beans imported from (redacted)

The full warning letter can be viewed here.

S&S Quality Wholesale Inc.
El Cajon, CA

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

In a June 1, 2022, warning letter, the FDA described a Feb. 14-16, 2022, Foreign Supplier Verification Program (FSVP) inspection of S&S Quality Wholesale Inc. in El Cajon, 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. Specifically, they did not develop an FSVP for each of the following foods:

• Bashan Koftelik Bulgur Fine imported from (redacted), located in (redacted)
• Bread Sticks imported from (redacted), located in (redacted)
• Wheat Kernal Habiya imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

Fuentes Farms 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 Oct. 14, 2022, warning letter, the FDA described a July 28 – Aug. 1, 2022, Foreign Supplier Verification Program (FSVP) inspection of Fuentes Farms 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. Some of the significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:

• green onions imported from foreign supplier (redacted)
• chayote imported from foreign supplier (redacted)
• broccoli imported from foreign supplier (redacted)

The full warning letter can be viewed here.

Leimax Corp.
Yonkers, NY

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

In an Oct. 7, 2022, warning letter, the FDA described an April 5-19, 2022, Foreign Supplier Verification Program (FSVP) inspection of Leimax, Corp. in Yonkers, NY.

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. Specifically, they did not develop an FSVP for each of the following foods:

• Lollipops (redacted) manufactured by (redacted).
• Cola flavored soft drink manufactured by (redacted).
• (Redacted) hot sauce manufactured by (redacted).

The full warning letter can be viewed here.

TL State Management Inc.
Brooklyn, NY

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

In an Aug. 30, 2022, warning letter, the FDA described a March 21 through April 18, 2022, Foreign Supplier Verification Program (FSVP) inspection of TL State Management, Inc. in Brooklyn, NY.

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. Specifically, they did not develop an FSVP for each of the following foods:

• Pickled red tomatoes from (redacted)
• Puff pastry dough from (redacted)
• (Redacted) wafers from (redacted)

The full warning letter can be viewed here.

San-Rey Produce Inc.
Pharr, 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 Dec. 7, 2022, warning letter, the FDA described an Aug. 11-19, 2022, Foreign Supplier Verification Program (FSVP) inspection of San-Rey Produce Inc. in Pharr, 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. Specifically, they did not develop an FSVP for each of the following foods:

• onions imported from foreign supplier, (redacted)
• (Redacted) limes imported from foreign supplier, (redacted)
• coriander imported from foreign supplier, (redacted)

The full warning letter can be viewed here.