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.

Sunrise Distributors Inc., Elk Grove Village, IL
Farhan Karim, vice president
In a Feb. 11, 2020, warning letter the FDA described a Dec. 5 followup and new inspections at Sunrise Distributors Inc., Elk Grove Village, IL. Inspectors found serious violations of federal law at the business.  

The inspections were conducted to determine compliance with the requirements of the federal food code and the U.S. Foreign Supplier Verification Program. The FSVP regulation requires that importers perform certain risk-based activities to verify that food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.

“During the most recent inspection, we found that you are not in compliance with the requirements the FSVPs for (redacted by FDA) imported from (redacted); fried onions imported from (redacted); and basmati rice imported from (redacted). Your firm did not have FSVPs for these products. 

“At the conclusion of both the initial FSVP inspection on July 9, 2018, and the followup inspection on Dec. 5, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations, according to the warning letter.

“We have not received your response to either Form FDA 483a. Although you indicated in an email dated January 16, 2020 that you were working on a response, FDA has not yet received one.”

Sweet Ann Cake Inc., Toa Baja, Puerto Rico
Francisco Aguayo Medina, president
During a month-long inspection in the summer of 2019, FDA staff found “serious violations” of federal law at the company’s Toa Baja, Puerto Rico, facility, according to the warning letter dated Oct. 29, 2019. Problems included violations of the “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.”  

Based on FDA’s inspectional findings, the agency determined that the bakery products manufactured in your facility are adulterated within the meaning of applicable U.S. law in that they were prepared, packed, or held under unsanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. 

FDA’s inspection resulted in issuance of an FDA Form 483 Inspectional Observations report listing deviations. The firm responded Aug. 1, 2019, but the agency’s warning letter says the response was inadequate.

Violations included failure to conduct a hazard analysis of all products. Consequently, the inspectors reported the following problems:

  • The firm did not identify allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control. The facility manufactures multiple products with different allergen profiles on the same day and on shared equipment.
  • The firm did not identify pathogens, such as Clostridium botulinum, pathogenic E. coli, Salmonella, and/or Staphylococcus aureus, as a known or reasonably foreseeable hazard to determine whether pathogens are a hazard requiring a preventive control. The facility manufactures multiple products with wheat flour, peanuts, and/or tree nuts such as almonds. These ingredients have been associated with pathogens.
  • The firm did not evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, as a known or reasonably foreseeable hazard. Specifically, the facility manufactures ready-to-eat (RTE) food which is exposed to the environment prior to packaging. The packaged foods, such as your mousse products that contain unpasteurized eggs, do not receive a treatment or otherwise include a control measure that would significantly minimize the pathogen. In addition, after the firm’s baked products have undergone (redacted by FDA), they are re-exposed to the environment uncovered and held under ambient temperature without refrigeration for an extended period of time before being processed or packaged for distribution.
  • The firm did not identify mycotoxins as a known or reasonably foreseeable hazard to determine whether mycotoxins are a hazard requiring a preventive control. Your facility manufactures multiple products with wheat flour, peanuts, and/or tree nuts (such as almonds). These ingredients have been associated with mycotoxins.
  • The firm not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in its facility, as required by federal law.
  • The firm did not identify and implement preventive controls, such as process controls, allergen controls, and supply-chain controls, for any products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented.

Pest control was also a problem at the facility and the warning letter cited numerous findings by inspectors, including:

Apparent rodent excreta pellets too numerous to count in the (redacted) area where a variety of paper bags of ingredients such as creme cake base, white cake mix, baking powder, and the paper towel used for drying hands are stored; and (redacted) on the floor of the (redacted) area next to a storage rack where cleaned baking pans were stored.

A bird’s nest with two live birds as well as bird droppings were observed at the entry ramp to the (redacted) dock where distribution trucks were loaded with unpackaged and partially uncovered RTE bakery products.

Flying insects were observed in the production area where RTE cheesecakes and cakes are decorated, flying over food contact surfaces of (redacted) tables and racks with RTE bakery products ready for distribution. One flying insect was observed to have landed on the food contact surface (redacted) table and a measuring cup in the (redacted) production area.

Inspectors also noted numerous improper and ineffective cleaning and maintenance practices including the following:

  • The firm did not adequately maintain equipment and utensils to protect against allergen cross-contact and contamination.
  • Knives used to test if the bakery products are fully cooked, cut the crust, and sculp the RTE bakery products were held in contact with dirty surfaces and used to open dusty packages of ingredients without being cleaned and sanitized prior to using on the RTE bakery products.
  • Processing utensils and tools such as measuring cups, sifters, and spatulas were dirty with old food residues and/or corroded parts.
  • An employee dropped a spatula that is used to glaze the RTE cheesecake on the floor and then returned it to the (b)(4) table.
  • The firm did not clean food contact surfaces of equipment as frequently as necessary to protect against allergen cross-contact and against contamination of food. Specifically, product contact surfaces of working tables used for raw and finished product preparations were not cleaned and sanitized before use and/or between uses.
  • The firm did not store clean and sanitized (b)(4) equipment with food-contact surfaces and utensils in a location and manner that protects food contact surfaces from allergen cross-contact and from contamination. Specifically, an investigator observed processing utensils, such as clean baking pans and baking sheets, stored uncovered under processing tables that had rusted parts, accumulated dirt, and old food residue underneath the tables. Furthermore, product contact surfaces of the clean baking pans and trays used to hold RTE product were in direct contact with the corroded parts of the tables. In addition, product contact surfaces of the clean baking pans and trays were in direct contact with corroded metal and (b)(4) surfaces of a storage rack.
  • An employee did not wash his hands thoroughly in an adequate handwashing facility when his hands may have become soiled or contaminated. Specifically, prior to an employee decorating RTE cheesecakes with his bare hands, he was observed scratching his arms and touching dirty surfaces around the production area, such as a visibly dirty shopping cart, (b)(4) cartons, and dirty processing tools without washing his hands between changing tasks and handling RTE products.
  • Uncovered RTE products were exposed to dust build-up and an apparent black mold-like substance on the ceiling of the (b)(4) cooler.
  • There was mold on the door frame and (b)(4) curtain at the entrance to the (b)(4) cooler, through which uncovered RTE bakery products are transported.
  • The firm did not maintain plumbing adequately to avoid it constituting a source of contamination to food, water supplies, equipment, or utensils or creating an insanitary condition.
  • The outer surface of the hoses used to provide (b)(4) water in the processing area, including use by employees to rinse their hands and utensils, was visibly dirty.
  • Employees obtained (b)(4) water from an (b)(4) hose attached to a water (b)(4) cartridge on the (b)(4) water line.

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