As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not displayed to the public until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a business has been given months, if not years, to correct the issues. The FDA frequently writes parts of warning letters that are published in public view.

ITC World Trade Inc.
Houston, TX

A Texas import company has been issued formal notice by the FDA for not having FSVPs for a number of imported food products.

In an October 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.

FDA inspection found that the company was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.

The company has not developed, maintained or monitored FSVP for any of the foods it imports, 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 and feed meet applicable FDA safety standards.

The full warning letter can be viewed here.

Candy from Maribel, Inc.
Brooklyn, New York State

A New York-based food company has been challenged by the FDA for serious violations of the Federal law on food, drugs and cosmetics and the current regulations on good manufacturing practices, risk analysis and preventive controls based on risks for human consumption.

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

FDA inspection found that the company was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.

Specifically, the FDA has determined that ready-to-eat chocolate products manufactured at the company’s plant are adulterated within the meaning of Section 402 (a) (4) of the Federal Food, Drug, and Cosmetic Act in that they have been prepared, packaged or stored in unsanitary conditions during which they may have been contaminated with dirt or made dangerous to health.

Some of the violations:

Current Good Manufacturing Practices (Subpart B):

1. The company failed to maintain buildings, fixtures and other physical facilities in an adequate state of cleanliness and hygiene and in good repair to prevent food from being adulterated.

• The skylight, located above the quenching machine inside the processing room, had exposed paint hanging from its metal bars. The tempering machine contained melted dark chocolate and remained uncovered throughout the inspection.
• The floor inside the company’s treatment room exhibited chipped, cracked surfaces.

2. The company did not clean food contact surfaces as often as needed to protect against allergen cross-contact and food contamination.

• 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 because food residues were observed on the trays.
• On June 2, 2021, after cleaning on a metal grid, chocolate residue was stuck to the grid extension, which was reattached to the cooling tunnel which was ready for production for the next shift.

3. The company failed to take adequate precautions to ensure that production procedures do not contribute to cross-contact with allergens and contamination from any source.

• On June 1, 2021, the company filled, repackaged 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 molds filled with dark chocolate, 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 going through the ceiling and the plastic covering the unused equipment. The company manufactures different types of chocolate products that may contain different allergens in the same room using the same method to cool the chocolate.
• Typical company practice is to store clean chocolate bar molds on a rack protected by plastic wrap. On June 1, 2021, the molds containing chocolate residue were stored on the clean mold storage medium. An employee explained that these molds were used to make milk chocolate bars and that they had been placed on the clean rack by mistake. The employee added that the establishment has designated molds for the milk and dark chocolate bars; however, these molds are identical. The facility does not have a system in place to monitor cleaning and differentiate between the two mussels.

4. The company has failed to take reasonable measures and precautions to ensure that all people working in direct contact with food wash their hands thoroughly – and disinfect themselves if necessary to protect against micro-contamination. unwanted organisms – before starting work, after every absence from work and at any time. other time when the hands may be soiled or contaminated. Specifically, on June 1, 2021, two employees were observed returning to the treatment room after taking their breaks, and they proceeded to process the ganache without washing or disinfecting their hands.

The full warning letter can be viewed here.

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