The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.


Baja Best Distributing Inc.
San Diego, 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 May 1 warning letter, the FDA described a June 8 to 28, 2023 Foreign Supplier Verification Program (FSVP) inspection of Baja Best Distributing, Inc. in San Diego, 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:

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

  • Fresh cucumbers and fresh strawberries from (redacted by the FDA) located in (redacted by the FDA), Mexico.

The full warning letter can be viewed here.

Genpro Imports & Export Inc.
Pico Rivera, 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 May 14 warning letter, the FDA described a Dec. 13, 2023, Foreign Supplier Verification Program (FSVP) inspection of Genpro Imports & Exports Inc. in Pico Rivera, 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:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, the firm did not develop, maintain, and follow an FSVP for any foods that they import, including the following foods:

  • Summer squash, eggplant, and bitter melon, imported from (redacted by FDA), located in Mexico.

The full warning letter can be viewed here.

Amin Trading Agency LLC
Edison, NJ

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

In a May 5, 2024  warning letter, the FDA described a Dec. 27, 2023, through March 4, 2024, Foreign Supplier Verification Program (FSVP) inspection of Amin Trading Agency LLC in Edison, NJ.

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:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, the firm did not develop, maintain, and follow an FSVP for the foods from the foreign suppliers indicated in the attached list they import, including the following foods:

  • Masala E Magic from (redacted by FDA) located in India
  • Garam Masala from Everest Food Products located in India
  • Sambar Masala from Everest Food Products located in India

The full warning letter can be viewed here.

Rash Catering Services LLC
Dallas, 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 22 warning letter, the FDA described a Feb. 21 to 22 Foreign Supplier Verification Program (FSVP) inspection of Rash Catering Services 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:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the foods you import, including each of the following foods:

•    Yam Flour, imported from (redacted by FDA), located in (redacted by FDA)
•    Plantain Flour, imported from (redacted by FDA), located in (redacted by FDA)
•    Biscuits, imported from (redacted by FDA), located in (redacted by FDA)

The full warning letter can be viewed here.

La Sucursal Produce Inc.
Los Angeles, 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 March 1 warning letter, the FDA described an Oct, 25, 2023 ,Foreign Supplier Verification Program (FSVP) inspection of La Sucursal Produce Inc. in Los Angeles, 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:
The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop, maintain, and follow an FSVP for any of the foods that they import, including:

  • Husk Tomato imported from (redacted by FDA) in (redacted by FDA);
  • Green Onion imported from (redacted by FDA) in (redacted by FDA);
  • Peas imported from (redacted by FDA) in (redacted by FDA).

The full warning letter can be viewed here.

New India Bazar Inc.
Milpitas, 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 1 warning letter, the FDA described inspections on Nov. 14, Nov. 15, Dec. 4, Dec. 18, and Dec. 21, 2023, for the Foreign Supplier Verification Program (FSVP) of New India Bazar, Inc. in Milpitas, 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:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for the foods from the foreign suppliers indicated in the attached FSVP011 list, as well as the following foods:

  • Masala Munch Snack, imported from (redacted by FDA), located in India
  • Chat Papri, imported from (redacted by FDA), located in India
  • Gujarati Chavana (snack), imported from (redacted by FDA), located in India

The full warning letter can be viewed here.

Always Fresco LLC
Mission, 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 Feb. 22 warning letter, the FDA described a Nov. 29 and 30, 2023, Foreign Supplier Verification Program (FSVP) inspection of Always Fresco LLC located 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:
The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods that they import, including the following foods:

  • Carrots imported from (redacted by FDA) in (redacted by FDA)
  • Cilantro imported from (redacted by FDA) in (redacted by FDA)
  • Squash imported from (redacted by FDA) in (redacted by FDA)

The full warning letter can be viewed here.

Juquilita Mexican Imports LLC
Renton, WA

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

In a March 25 warning letter, the FDA described a Feb. 2 Foreign Supplier Verification Program (FSVP) inspection of Juquilita Mexican Imports LLC in Renton, WA.

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

  • Pasteurized String Cheese, imported from (redacted by FDA), located in (redacted by FDA)
  • Black Mole, imported from (redacted by FDA), located in (redacted by FDA)
  • Pumpkin Seeds, imported from (redacted by FDA), located in (redacted by FDA)

The full warning letter can be viewed here.

ISPE Produce Inc.
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 23 warning letter, the FDA described a Feb. 29 Foreign Supplier Verification Program (FSVP) inspection of ISPE Produce, Inc. 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:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, the firm did not develop an FSVP for any of the foods they import, including the following foods:

  • Fresh Roma Tomatoes imported from (redacted by FDA) located in (redacted by FDA)
  • Bell Peppers (Morron) imported from (redacted by FDA), located in (redacted by FDA)
  • Lettuce imported 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.)



Source link