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.

ITC Global Trading 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 an Oct. 22 warning letter, the FDA described an April 30 to May 19, 2021, Foreign Supplier Verification Program (FSVP) inspection of ITC Global Trading Inc. 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.

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

  •   Canned Mango and Passion Fruit Drink imported from (redacted)
  •   Water Chestnuts in Syrup imported from (redacted)
  •   Coconut Meat in Syrup imported from (redacted)

The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.

The full warning letter can be viewed here.

Maribel’s Sweets, Inc.
Brooklyn, NY

A food firm in New York is on notice from the FDA for serious violations of the Federal Food, Drug, and Cosmetic Act and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

In an Oct. 25 warning letter, the FDA described a June 1-17, 2021 inspection of Maribel’s Sweets, Inc.’s food manufacturing facility in Brooklyn, NY.

The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.

Specifically, the FDA, determined that the ready-to-eat chocolate products manufactured in the firm’s facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that they were prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

Some of the violations:

Current Good Manufacturing Practice (Subpart B):

  1. The firm did not keep buildings, fixtures, and other physical facilities in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated.
  • The skylight, located above the tempering machine inside the processing room, had apparent loose paint hanging from its metal bars. The tempering machine contained melted dark chocolate and was kept uncovered during the entire inspection.
  • The floor inside the firm’s processing room exhibited cracked peeling surfaces.
  1. The firm did not clean food contact surfaces as frequently as necessary to protect against allergen cross-contact and against contamination of food.
  • On June 1, 2021, employees were observed transferring ganache coming out of the cooling tunnel onto previously used disposable plastic trays. These trays were not clean, as food residue was observed on the trays.
  • On June 2, 2021, after cleaning was performed on a metal grid, chocolate residue was adhered to the grid extension, which was reattached to the cooling tunnel that was ready for the next shift’s production.
  1. The firm did not take adequate precautions to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
  • On June 1, 2021, the firm filled, repacked, and labeled two types of hot chocolate, one of which contains the allergen hazelnut. These two products were processed simultaneously, side by side, on the same processing table.
  • On June 1, 2021, while a fan was used to cool dark chocolate-filled molds, apparent chocolate dust was observed on many surfaces inside the processing room caused by the fan blowing on the dark chocolate. These surfaces included the pipes running across the ceiling and plastic covering unused equipment. The firm manufactures different types of chocolate products that may contain different allergens in the same room using the same method to cool the chocolate.
  • The firm’s typical practice is to store clean chocolate bar molds on a rack protected by plastic wrap. On June 1, 2021, molds that had chocolate residue were stored on the clean mold storage rack. An employee explained that these molds were used to make milk chocolate bars and were placed on the clean rack in error. The employee added that the facility has designated molds for milk and dark chocolate bars; however, these molds are identical. The facility does not have a system in place to monitor the cleaning and differentiate between the two molds.
  1. The firm did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly — and sanitize if necessary to protect against contamination with undesirable microorganisms — before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled or contaminated. Specifically, on June 1, 2021, two employees were observed returning to the processing room after taking their breaks, and they proceeded with processing ganache without washing and sanitizing their hands.

The full warning letter can be viewed here.

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