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.

Jam Jam Services, Inc.
Sunrise, FL

An import company in Florida 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 Jan. 25 through Feb. 3, 2022, Foreign Supplier Verification Program (FSVP) inspection of Jam Jam Services, Inc in Sunrise Florida.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

The firm did not develop an FSVP for any foods that they import, including the following foods:

• Powdered Scotch Bonnet Peppers, imported from (redacted), located in (redacted).
• Beverage Mix Coconut Flavor, imported from (redacted), located in (redacted).

The full warning letter can be viewed here.

La Serranita import and Export LLC
Elizabeth, 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 Sept. 19, 2022, warning letter the FDA described a March 30 through April 13, 2022, Foreign Supplier Verification Program (FSVP) inspection of La Serranita import and Export in Elizabeth, NJ.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which 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 for any of the foods they import, including each of the following:

• Frozen Corn Cobs imported from (redacted), located in (redacted)
• Frozen Whole Yellow Hot Pepper imported from (redacted), located in (redacted)
• Special White Cheese of Cayambe imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

J R imports 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 Nov. 9, 2022, warning letter the FDA described an Aug. 5-31, 2022, Foreign Supplier Verification Program (FSVP) inspection of J and R imports LLC in Mission, TX.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations which 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 for any of the foods they import, including each of the following:

• Prickle pear imported from (redacted), located in (redacted)
• Cilantro imported from (redacted), located in (redacted)
• Poblano peppers imported from (redacted), located in (redacted)

The firm imports fresh produce that is “covered produce.” As an importer of covered produce, they must have an FSVP that demonstrates that their 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 under section 419 of the FD&C Act (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

The full warning letter can be viewed here.