Three New Jersey food firms on notice from FDA because of 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.

Vibrant Enterprise LLC
Iselin, 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 Nov. 24, 2020, warning letter, the FDA described a July 14 through Aug. 4, 2020, remote Foreign Supplier Verification Program (FSVP) inspection at Vibrant Enterprise LLC.

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 each of the following foods:

Tamarind Paste imported from their foreign supplier (redacted)
Chatpata Chaat Makhana Pops (Roasted Fox Nuts) imported from their foreign supplier (redacted)
Kesar Mango Pulp imported from their foreign supplier (redacted)
Canned Sarson Ka Saag (Curried Mustard Leaves) imported from their foreign supplier (redacted) and (redacted)

The full warning letter can be viewed here.

My Habitat Brands LLC
Dayton, 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 Feb. 3 warning letter, the FDA described an Oct. 9 through 21, 2020, remote Foreign Supplier Verification Program (FSVP) inspection at My Habitat Brands LLC.

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 each of the following foods:

chocolate bar and chocolate dairy mix imported from (redacted), located in (redacted)
botanas puffed snack imported from (redacted) located in (redacted)

The full warning letter can be viewed here.

JR & Son World Trading LLC
Iselin, 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 Feb. 3 warning letter, the FDA described an Oct. 14 through Nov. 10, 2020, remote Foreign Supplier Verification Program (FSVP) inspection at JR & Son World Trading LLC.

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 each of the following foods:

The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During the inspection, they provided copies of their foreign supplier (redacted) hazard analysis for Guava Paste, their foreign supplier (redacted) hazard analysis for Yellow Pepper Dices, and their foreign supplier (redacted) hazard analysis for Coconut Water and Milk Drink Group. However, for each of these products, they did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis.
For a low-acid canned food, the firm did not verify and document that the food was produced according to the low-acid canned foods regulations. Specifically, for a low-acid canned food, they did not document that the food (Coconut Water with Pulp) was produced according to the low-acid canned food regulations. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards, they must verify and document that the food was produced in accordance with 21 CFR part 113. The firm did not verify and document that their Coconut Water with Pulp was produced in accordance with 21 CFR part 113.
The firm did not approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food and document their approval. Specifically, for their foreign suppliers (redacted) they did not evaluate their foreign supplier’s performance and the risk posed by the food, approve their foreign supplier on the basis of this evaluation, and document their approval.
The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their use of these procedures.
The firm did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food they import. Specifically, they did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the Guava paste that they imported from (redacted) and the Coconut Water with Pulp imported from (redacted).
The firm did not meet the requirements to conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter. Specifically, they did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food (Guava Paste from (redacted), Coconut Water with Pulp, or Yellow Peppers Dices from (redacted)) into the United States.