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.

Iacofano’s Group LLC, Charleston, SC
John L. Iacofano, owner

In a May 28 warning letter the FDA described a Jan. 7-22, 2020, inspection at Iacofano’s Group LLC’s ready-to-eat food manufacturing facility. Inspectors found that the company had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.

FDA’s inspection resulted in issuance of an FDA Form 483a. The significant violations are as follows:

Hazard Analysis and Risk-Based Preventive Controls:

When FDA requested their food safety plan during the inspection, they provided documents titled “Iacofano’s Catering & Foodservice Standard Operating Procedure” and “HACCP-based SOPs.” As explained below, these documents collectively contain some but not all required elements of a food safety plan.

  1. They did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility, including their RTE brownies, macadamia nut cookies, and grape products to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control.
  2. They did not identify and evaluate food allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures various products with different allergen profiles on the same day and on shared equipment, such as cutting boards and knives, which can result in allergen cross-contact without appropriate controls.
  3. They did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard to determine whether environmental pathogens are a hazard requiring a preventive control. Their 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.
  4. They 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 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. They have established some preventive controls, e.g., their “HACCP-based SOPs” include process controls in their procedures for “Cooking Potentially Hazardous Foods” and “Cooling Potentially Hazardous Foods.” However, the firm lacks other preventive controls such as food allergen controls. Their manager provided their “HACCP-Based SOP” titled “Preventing Cross-Contamination During Storage and Preparation” as their allergen control program; however the document does not mention allergens or include all the procedures, practices, and processes to protect food from allergen cross-contact and ensure that the finished food is not misbranded.
  5. They did not document the monitoring of preventive controls. When monitoring records were requested on January 8, 2020, they were only able to provide blank records.
  6. They manufacture RTE food that is exposed to the environment at numerous stages of manufacturing and does not receive a subsequent control to significantly minimize or prevent environmental pathogens. They have identified sanitation control procedures (e.g., Equipment Cleaning and Sanitizing) in their “Standard Operating Procedures,” and they have an Environmental Monitoring Program. However, they did not implement their environmental monitoring procedures. Specifically, their environmental monitoring program states that they will conduct environmental swabbing for Listeria spp., Salmonella, and total coliform/E. coli at specific frequencies depending on the location. The frequencies are as follows: (redacted). However, they stated during the inspection that only (redacted) locations are (redacted). Further, their most recent analytical results, dated July 17, 2019, only show results for Listeria.

Current Good Manufacturing Practices (Subpart B)

  1. They did not take reasonable measures and precautions to ensure persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food.
  2. On January 7 and 8, 2020, multiple employees were observed wearing gloves and handling insanitary objects before returning to handling food, food contact surfaces, and processing utensils without changing gloves. On January 8, 2020, an employee was observed handling food with torn gloves.
  3. On January 7, 2020, an employee was observed handling Macadamia Nut Cookies, which contain the major food allergens wheat, soy, milk, tree nuts, and egg, and then without changing their gloves handling bread for another product which was only labeled as containing wheat and soy.
  4. They did not maintain their plant in a clean and sanitary condition or keep their plant in repair adequate to prevent food from becoming adulterated:
  5. The ceiling in the kitchen and the food preparation rooms were observed to be rusty, sagging, discolored, and in disrepair.
  6. A ceiling vent in front of the preparation room freezer was observed to be covered in filth.
  7. Floor tiles were observed to be loose in multiple locations in the packing room and kitchen, preventing adequate cleaning.
  8. The floor threshold in front of kitchen freezer (redacted) was observed to be deeply pitted with exposed wood, which is a surface that is not easily cleanable.
  9. A residue was observed on shelves used to hold clean utensils.
  10. The drain tubes for the freezers in the facility were observed to have built up frozen condensate on them, and in preparation room freezer (redacted) a cooler on the freezer floor was encased in frozen condensate.
  11. They did not clean their non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials. Specifically, on January 7 and 8, 2020, FDA investigators observed:
  12. Multiple shelves directly over food preparation areas had dust build up and debris.
  13. Multiple utensil storage racks contained a residue build up on surfaces where cleaned utensils were stored.
  14. Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties. They did not establish and maintain documentation of this training. During the inspection, their Manager stated that employees undergo on-the-job training as well as Employee Health Training and Employee Food Safety Training; however, their firm was unable to provide any completed training records to demonstrate the employees had received any training.

The full warning letter can be viewed here.

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