Import firms across the U.S. warned about foreign supplier verification 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.

Ada Teff
Garland, 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. 12, 2022, warning letter, the FDA described a Sept. 19-22, 2022, Foreign Supplier Verification Program (FSVP) inspection at Ada Teff in Garland, 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 foods that they import, including the following foods:

(Redacted) Flour imported from foreign supplier (redacted) located in (redacted)
(Redacted) Flour imported from foreign supplier (redacted) located in (redacted)

The full warning letter can be viewed here.

Golden Bridge Gourmet, Inc. DBA Golden Bridge
Sun Valley, 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 Jan. 12 warning letter, the FDA described a July 18, 2022, Foreign Supplier Verification Program (FSVP) inspection at Golden Bridge Gourmet, Inc. in Sun Valley, 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 significant violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for the foods indicated in the list below, including, but not limited to, the following foods they import:

Bread, cookies, biscuits and wafers manufactured by (redacted), located in (redacted)
Cookies, biscuits, wafers, pastry and bread sticks manufactured by (redacted), located in (redacted)
Spaghetti and noodles manufactured by (redacted), located in (redacted)
Chutney, candy, chocolates manufactured by (redacted), located in (redacted)
Bread sticks manufactured by (redacted), located in (redacted)
Cookies, biscuits, and wafers manufactured by (redacted), located in (redacted)
Biscuits, bread, cookies, and cakes manufactured by (redacted), located in (redacted)
Tomato (dried), asparagus, mixed vegetable, and relish manufactured by (redacted), located in (redacted)

2. The firm must approve their foreign suppliers on the basis of an evaluation of their foreign supplier’s performance and the risk posed by the food for the products they import.

3. The firm did not meet the requirement to perform foreign supplier verification activities as required. Specifically, they did not establish written procedures for ensuring that appropriate supplier verification activities are conducted, and they did not document their determination of the appropriate supplier verification activity or activities or the frequency with which the activity or activities must be conducted, as required.

4. The firm must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, the firm must provide within a reasonable time an English translation of records maintained in a language other than English. However, they did not provide an English translation of the FSVP documents attached to their Sept. 16, 2022, response to the FDA Form 483a, even after FDA’s Oct. 3, 3022 request for the referenced documents in English: hazard analysis (partially translated into English) for the Le Sfogliette Dorate Biscuits, imported from (redacted); hazard analysis, flow chart, and copies of documents entirely in a foreign language that appear to relate to the importation of Black Olives and Unseasoned Black Olive Paste from (redacted) in (redacted). As of when the warning letter was sent, the firm has still not provided the requested translation of these documents.

The full warning letter can be viewed here.

Capital Imports LLC
Minneapolis, MN

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

In a Feb. 22, 2023, warning letter, the FDA described a Nov. 4 through Dec. 15, 2022, Foreign Supplier Verification Program (FSVP) inspection of Capital Imports LLC in Minneapolis, MN.

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 an FSVP for any of the foods they import, including the following foods:

Sanora Peri Peri Garlic Sauce imported from (redacted)
Ghee Butter imported from (redacted)
Chickpeas; canned imported from (redacted)

The full warning letter can be viewed here.

J&H Imports Services Corp
New York, 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 a Jan. 3 warning letter, the FDA described an Aug. 29 through Sept. 12, 2022, Foreign Supplier Verification Program (FSVP) inspection of Select Produce 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 foods they import, including the following foods: