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.

Nassif Wholesale LLC, Palm Springs, FL
Paul Nassif, owner

In a March 19, 2020, warning letter the FDA described a Jan. 31 Foreign Supplier Verification Program (FSVP) inspection at Nassif Wholesale LLC. Inspectors found that the company was not in compliance with the federal FSVP regulation. The agency’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations.

The FDA’s inspection revealed the following violations:

The firm did not develop an FSVP for each of the following foods:

  • Sesame seeds and tahini imported from (redacted).
  • Tahini imported from (redacted).
  • Semolina imported from (redacted).

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, the owners are responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.

The firm must take prompt action to correct the  violations. If the owners do not promptly correct them, federal officials may take further action. The FDA may refuse admission of sesame seeds and tahini imported from (redacted); tahini imported from (redacted); and semolina imported from (redacted). The FDA may place the foods on detention without physical examination at U.S. ports of entry.

The full warning letter can be viewed here.

Portland Sandwich Company, Portland, OR
Myong S. Bracy, owner

In an April 3, 2020, warning letter the FDA described a Dec. 2-6, 2019, inspection at Portland Sandwich Campany’s ready-to-eat sandwich facility. Inspectors found that the company has serious violations of the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food law. The agencys inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations.

The FDA inspection revealed the following violations:

Hazard Analysis and Risk-Based Preventive Controls:

  1. The firm did not conduct a hazard analysis for any of thier products. Specifically, they did not identify and evaluate known or reasonably foreseeable hazards for each type of food products manufactured or processed at their facility to determine whether there are any hazards requiring a preventive control.
  2. They did not identify and evaluate allergen cross-contact to determine whether it is a hazard requiring a preventive control. Their facility manufactures various products with different allergen profiles on the same day and on shared equipment.
  3. They did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control. Their facility receives, stores, and manufactures various products that contain allergens such as fish, milk, peanuts, and eggs.
  4. The firm did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control. The facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or downstream customer) that would significantly minimize the pathogen.
  5. The firm did not identify and evaluate the biological hazard of bacterial growth due to a lack of time/temperature control during the storage of their variety of RTE closed-face meat and cheese sandwich products as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control.
  6. The firm did not identify and evaluate biological hazards such as Salmonella as know, or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. The facility manufactures/processes food with peanut butter. This ingredient has been known as a common source of a biological hazard (Salmonella).
  7. The firm did not identify and evaluate chemical hazards such as mycotoxins as known, or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control. The facility manufactures/processes food with wheat bread and peanut butter. These ingredients have been known as a common source of a chemical hazard (aflatoxin).
  8. 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, processed, packed, or held by their facility will not be adulterated. 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.

The firm’s “Egg Salad Sandwich HACCP Plan” dated Feb. 15, 2018, only partially addresses this requirement, and they did not have HACCP plans for other foods that they manufacture. The firm did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in their facility. A food safety plan must include the following:

  • The written hazard analysis.
  • The written preventive control.
  • The written supply-chain program.
  • The written recall plan.
  • The written procedures for monitoring the implementation of the preventive controls.
  • The written corrective action procedures.
  • The written verification procedures.

Current Good Manufacturing Practice (Subpart B):

  1. All persons working in direct contact with food, food-contact surfaces, and food packaging-materials did not conform to hygienic practices while on duty to the extent necessary to protect against contamination of food.
  2. Employees were observed changing tasks without discarding their gloves and washing their hands. Employees at the sandwich preparation station were observed entering the walk-in cooler to retrieve an ingredient, bringing the ingredient back to their designated preparation station, and resuming sandwich assembly without discarding their gloves and washing their hands.
  3. An employee with bare hands was observed picking up and consuming meat and cheese from one of the sandwich preparation stations while other employees were preparing RTE sandwiches.
  4. The firm did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food.
  5. A (redacted) veggie wash container was stored on the floor underneath the food preparation sink. Employees were observed placing the veggie wash container on the food preparation sink while washing lettuce and other produce.
  6. The bread rack trays containing debris and dirt residues were being used to store washed lettuce.
  7. Employees were observed placing a box of meat directly on top of a food preparation station where sandwiches were being assembled

The full warning letter can be viewed here.

Fatima Brothers, Maspeth, NY
Mohammad S. Islam, president

In an April 7, 2020, warning letter the FDA described a Feb. 13 Foreign Supplier Verification Program (FSVP) inspection at Fatima Brothers Inc. Inspectors found that the company was not in compliance with the FSVP regulation.

The agency’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The firm did not develop, maintain, and follow an FSVP. Specifically, the firm did not develop an FSVP for each of the following foods:

  • (redacted) Boiled Rice imported from (redacted)
  • (redacted) imported from (redacted)
  • (redacted) (Cake rusk) imported from (redacted)

The full warning letter can be viewed here.

Prime Line Distributors, Inc., Ft. Lauderdale, FL
Dennis Landi, vice president

In an April 9, 2020, warning letter the FDA described a Feb. 12 Foreign Supplier Verification Program (FSVP) inspection at Prime Line Distributors Inc. Inspectors found that the company was not in compliance with the FSVP regulation.

The agency’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The firm did not develop, maintain, and follow an FSVP. The firm did not develop FSVPs for each of the following foods:

  • Hazelnut Paste imported from (redacted).
  • Gran Padano Cheese and Parmigiano Reggiano Cheese imported from (redacted).

The full warning letter can be viewed here.

Allied Food Products Inc, Lindon, NJ
Isaac Stern, general manager

In an April 14, 2020, warning letter the FDA described a Feb. 13 to March 9 inspection at Allied Food Products Inc’s acidified food and dry food mix manufacturing facility. Inspectors found that the company was not in compliance with  the Emergency Permit Control regulation

The FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The agency inspection revealed the following violations:

  1. As a commercial processor engaged in the thermal processing of acidified foods, the firm must, no later than 60 days after registration and prior to the packing of a new product, provide the FDA information as to the scheduled process including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the established process, for each acidified food in each container size. FDA inspection revealed that the firm failed to file a scheduled process with FDA for thier shelf-stable acidified products, including, but not limited to, Garlic in Oil; Hot Sauce; Gravy Booster & Color Sauce; Deluxe Barbecue Sauce; Sweet & Smoky BBQ Sauce; and Ranch, Italian, French, Thousand Island, Russian, Creamy Italian, and Caesar salad dressings. To date, the firm has not filed scheduled processes for their acidified foods.
  2. The firm does not process acidified foods to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of non-health significance capable of growing in food. Specifically, their manufacturing and packaging processes for Garlic in Oil; Hot Sauce; Gravy Booster & Color Sauce; Deluxe Barbecue Sauce; Sweet & Smoky BBQ Sauce; and Ranch, Italian, French, Thousand Island, Russian, Creamy Italian, and Caesar salad dressings do not include a (redacted). They also do not have documentation of the effectiveness of the (redacted) used in these products, and do not conduct microbiological testing of these products for pathogens or spoilage organisms. In addition, these products are manufactured at (redacted) and not labeled to be stored under refrigeration. FDA investigators observed that they do not take the initial pH of these products during the manufacturing process, and they do not document the pH of the product before packaging.
    • The firm’s response, dated March 24, 2020, includes copies of microbiological testing that they say was conducted “to confirm the effectiveness of [their] process.” They provided testing records for Hot Sauce, Garlic in Oil, Gravy Booster, BBQ Sauce, Salsa, Italian, Tartar Sauce, and Thousand Island Dressing. All of these samples appear to have arrived at the lab on the same day, February 19, 2020. These samples, without more, are a snapshot in time that can be used as a verification step, but they are not a process validation and the Agency is unable to consider these results proof of correction.
  1. Operators of processing and packaging systems are not under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. The firm’s employees do not manufacture acidified foods under the supervision of a person with appropriate training and experience in the acidification and processing of acidified foods. In addition, no one in thier facility has attended a Better Process Controls course or any other approved FDA training in the manufacturing of acidified foods.
  2. The firm did not test and examine containers often enough to ensure that the containers suitably protected the food from leakage and contamination. They did have evidence of examinations or testing of the integrity of the glass and plastic container-closure systems in which their acidified products are packaged.
  3. Records are not maintained of the examination of finished products to verify compliance with FDA regulations and guidelines on action levels. FDA investigator requested batch records from Jan. 2019 to Feb. 2020 for review. The firm only provided one batch record for each of the following products: Garlic in Oil, Hot Sauce, Gravy Booster & Color Sauce, and Caesar salad dressing. No batch records were provided for Ranch, Italian, French, Thousand Island, Russian, and Creamy Italian salad dressings. For the batch records that were provided, only the (redacted) was documented. The batch records did not contain information for the (redacted), (redacted), or (redacted) of the products. In addition, they did not provide records that document calibration of (redacted) used to measure (redacted) in their acidified products.

The full warning letter can be viewed here.

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