October 2019: FDA Warning Letters to Food Companies

We took a snapshot of the seven warning letters FDA sent to food and dietary supplement companies that were posted in October.  Violations range from misbranding to the presence of Listeria monocytogenes.

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DIETARY SUPPLEMENTS | Alternative Laboratories

Alternative Laboratories (Naples, FL) received a warning letter on September 18, 2019 based on the outcome of an inspection ending June 10, 2019.

The firm uses DMHA in a number of products and lists it as a dietary ingredient on product labels.  FDA states that they do not recognize DMHA as a dietary ingredient and deems it adulterated.

FDA also considers the firm’s CBD oil, labeled as a dietary supplement, as an unapproved new drug.

DIETARY SUPPLEMENTS | Ibitta Enterprises, Inc.

Ibitta Enterprises, Inc. (South Gate, CA) received a warning letter on September 27, 2019 based on the outcome of an inspection ending May 21, 2019.

Violations include but are not limited to:

  • The firm failed to establish specifications for each dietary supplement for identity, purity, strength, and composition of the finished batch.  The firm also failed to establish specifications for limits on types of contamination that may adulterate or may lead to adulteration of the finished batch.
  • The firm failed to establish specifications for each component used in the manufacture of a dietary supplement, including identity specifications and specifications necessary to ensure the purity, strength, and composition of dietary supplements manufactured using the components.
  • The firm failed to establish specifications for dietary supplement labels.
  • The firm failed to prepare and follow a written master manufacturing record (MMR) that identifies specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
  • The firm’s batch production record (BPR) failed to include complete information relating to the production and control for each batch.
  • Product is misbranded in that the product labels fail to declare the common or usual names of each ingredient.
  • Product is misbranded in that the product labels contain information in two languages but do not repeat all the required information in both languages.
  • Product is misbranded because the serving size declared on the label is incorrect.
  • Product is misbranded in that the labels fail to identify the part of the plant from which each botanical dietary ingredient in the product is derived.

FOOD & BEVERAGES | Hans Kissle Company, LLC

Hans Kissle Company, LLC (Haverhill, MA) received a warning letter on September 24, 2019 based on the outcome of an inspection ending April 5, 2019.  The inspected facility manufactures ready-to-eat (RTE) salads and RTE prepared foods.

FDA laboratory analysis of environmental swabs from the facility revealed the presence of Listeria monocytogenes.  FDA states that one strain was the same found in the facility’s 2017 and 2018 inspections.

The firm responded to two 483s issued on April 5, 2019 and April 26, 2019 with a summary of corrective actions taken and planned.  FDA reminds the firm in the warning letter to provide detailed information on their actions.

FOOD & BEVERAGES | Harold Brey & Sons Inc.

Harold Brey & Sons Inc. (Jeffersonville, NY) received a warning letter on September 24, 2019 based on the outcome of an inspection ending May 29, 2019.  FDA inspected the company’s shell egg farm, including a processing plant were eggs are cleaned and packaged.

Violations include but are not limited to:

  • The farm failed to conduct environmental testing for Salmonella Enteritidis (SE) in the poultry house when laying hens are 40 to 45 weeks of age.
  • The company failed to properly implement its written SE prevention plan and failed to take the required number of samples for environmental testing using a sampling plan appropriate to the poultry house layout.
  • The SE prevention plan failed to address when monitoring indicates unacceptable rodent activity within a poultry house.
  • The SE prevention plan does not indicate when cleaning will be done.

DRUGS | Herbal Healer Academy, Inc.

Herbal Healer Academy, Inc. (Mountain View, AR) received a warning letter on September 12, 2019 based on the outcome of an inspection ending November 9, 2018.  FDA states that claims made on the company’s website establish that at least 20 products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

In addition, violations include but are not limited to:

  • The firm failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that were distributed.
  • The firm failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements.
  • Product is misbranded because the label fails to accurately declare the net quantity of contents on the principal display panel.
  • Product is misbranded in that the product label fails to declare the common or usual names of each ingredient used.
  • Product is misbranded because the serving size declared on the label is incorrect.
  • Product is misbranded in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36.
  • Product is misbranded in that the label fails to identify the part of the plant from which each botanical ingredient in the product is derived.

FOOD & BEVERAGES | Pollman’s Bake Shops, Inc.

Pollman’s Bake Shops, Inc. (Mobile, AL) received a warning letter on October 9, 2019 based on the outcome of an inspection ending June 13, 2019.  The bakery and central kitchen received a 483 at the end of the inspection, but had not yet sent a response at the date of warning letter issuance.

Violations include but are not limited to:

  • The company did not conduct a hazard analysis for any products.
  • The company did not identify 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 the facility will not be adulterated or misbranded.
  • The company did not prepare or have prepared and did not implement a written food safety plan for any product manufactured in the facility.
  • The company did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against contamination of food on the premises by pests.
  • The company did not maintain buildings, fixtures, and other physical facilities of the plant in a clean and sanitary condition and in repair adequate to prevent food from being adulterated.
  • The company did not clean and sanitize utensils and equipment as frequently as necessary to protect against allergen cross-contamination of food.
  • The company did not store cleaned and sanitized portable equipment as necessary to protect food-contact surfaces from allergen cross-contamination.
  • Product is misbranded in that the finished product labels fail to declare the major food allergen.
  • Product is misbranded because the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label.
  • Product is misbranded because the product labels fail to bear the common or usual name of the food.
  • Product is misbranded because the product labels fail to include the place of business of the manufacturer, packer, or distributor.
  • Product is misbranded because the product label fails to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count.

DIETARY SUPPLEMENTS | Paisley Farms, LLC dba Paisley Farm & Crafts

Paisley Farms, LLC dba Paisley Farm & Crafts (Lawrenceburg, TN) received a warning letter on June 4, 2019 based on the outcome of an inspection ending February 8, 2019.  FDA states that the claims made on the company’s Facebook page establish that the products are drugs because they are intended for the use in the cure, mitigation, treatment, or prevention of disease.  FDA then proceeds to address numerous violations under the umbrellas of Unapproved New Drugs, Adulterated Dietary Supplements, Misbranded Dietary Supplements, and Registration of Food Facilities.

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