Food companies in Michigan, Illinois and California warned about FDA 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.

Aroma Imports Inc.
Dearborn Heights, MI

An import company in Michigan is on notice from the FDA after it analyzed a sample collected from that shipment and detected Salmonella.

In a Dec. 23 warning letter, the FDA described an Aug. 5-26, 2021, Foreign Supplier Verification Program (FSVP) inspection of Aroma Imports Inc. in Dearborn Heights, MI.

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’s significant violations of the FSVP regulation are as follows:

1. During inspection the firm told the investigator that they were working on getting “letters of assurance” from their suppliers, but they did not have written assurances, as required, for most of the products they import including, Ajwa dates imported from (redacted) located in the (redacted) and tahina imported from (redacted) located in (redacted).
2. The firm did not document that they took appropriate corrective actions after they were notified about an adulteration issue with their foreign supplier of food they import. Specifically, on Jan. 5, 2021, the firm voluntarily destroyed a shipment of halawa they imported from (redacted) on or about Nov. 1, 2020, after FDA notified them that they analyzed a sample collected from that shipment, detected Salmonella, and determined the halawa was adulterated. FDA placed (redacted) on Import Alert # 99-19, “Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella” on Dec. 18, 2020. This foreign supplier remains on Import Alert #99-19.

Although the firm voluntarily destroyed the halawa on the shipment mentioned above, they again imported halawa with pistachio from (redacted) on or about June 27, 2021, without documenting what corrective actions were taken by in response to the Salmonella contamination. During the inspection the firm told FDA investigators that it had been in contact with the foreign supplier regarding the Salmonella findings in the products. The firm stated that (redacted) believed the source of the contamination was the sesame seed ingredient and that it had been taken care of by the firm. The firm also obtained a written assurance dated June 2, 2021. However, they did not document any corrective action.

The full warning letter can be viewed here.

International Golden Foods Inc.
Bensenville, IL

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

In a Dec. 15, 2021, warning letter, the FDA described inspections on June 29 to July 20, 2021, of International Golden Foods Inc. ready-to-eat (RTE) food facility in Bensenville, IL.

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.

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared, and did not implement a food safety plan. A food safety plan must include the following:

a) The written hazard analysis

b) The written preventive controls

c) The written supply-chain program

d) The written recall plan

e) The written procedures for monitoring the implementation of the preventive controls

f) The written corrective action procedures

g) The written verification procedures

1. The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically,
2. The firm did not identify and evaluate environmental pathogens, such as Salmonella, to determine whether they are a hazard requiring a preventive control to comply. Their facility repackages RTE foods which are exposed to the environment prior to packaging, such as roasted pistachios, shredded coconut, sesame seeds, chia seeds, and dried herbs and spices including dill, fenugreek, and sumac. Their RTE packaged foods do not receive a treatment or otherwise include a control measure that would significantly minimize pathogens. Note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control.
3. The firm did not identify and evaluate undeclared allergens to determine whether they are a hazard requiring a preventive control. Their facility repackages and relabels tree nuts (e.g., pistachios and shredded coconut), as well as products that contain wheat (e.g., dried pasta and wheat flour).
4. The firm did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Their facility repackages products with allergens (including pistachios, coconut, and wheat) on the same equipment as products without allergens. Allergen cross-contact could occur in products with different allergen profiles, without appropriate controls.
5. The firm did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, process, packed, or held by their facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply chain controls, and a recall plan. Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.

Current Good Manufacturing Practice:

1. The firm did not hold food that can support the rapid growth of undesirable microorganisms at temperatures that will prevent the food from becoming adulterated. Their facility stores soft fresh cheeses in their (redacted) cooler. On June 29, 2021, FDA investigator observed approximately (redacted) Feta (14 oz, lot 209124, Best Before Dec. 2021) and a mixed pallet of (redacted) Goat’s Milk Soft Cheese (35 oz, Best Before 10.30.2021) and (redacted) White Cheese (35 oz, Best Before 11.30.2021) stored in the cooler at the following temperatures:

• At approximately 10:45 am, the ambient temperature was measured at 59.5°F with an FDA-issued calibrated thermometer.
• At approximately 2:00 pm, the ambient temperature was measured at 60.9°F with an FDA-issued calibrated thermometer.

2. The firm did not adequately maintain equipment, utensils, and food-contact surfaces to protect against contamination. Specifically, FDA investigators observed a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. These surfaces are not easily cleanable and may be a source of cross-contamination with environmental pathogens such as Salmonella.
3. The firm did not exclude pests from their food plant to protect against contamination of food. Specifically, FDA investigators observed a live bird in their warehouse which opens directly to the repackaging room where its food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. Pests must be excluded from holding and processing areas in their plant to protect against contamination of food.

The full warning letter can be viewed here.

Tropic Trading Co.
Valley Center, 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 Dec. 6 warning letter, the FDA described an Aug. 11 and 13, 2021, Foreign Supplier Verification Program (FSVP) inspection of Tropic Trading Company in Pauma Valley, 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.

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

• Fresh Durian imported from (redacted) located in (redacted)
• Fresh Longan Fruit imported from (redacted) and (redacted) located in (redacted)
• Fresh Rambutan imported from (redacted) located in (redacted)

The FSVP requires importers to verify that their foreign suppliers of food meet applicable FDA safety standards.

The full warning letter can be viewed here.

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