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.

Greenwood Ice Cream LLC
Chamblee, GA

A food firm in Georgia is on notice from the FDA for serious violations after inspectors found Listeria in the company’s production facility.

In a Dec. 17, 2021, warning letter, the FDA described inspections on June 22-25, 2021, of Greenwood Ice Cream LLC in Chamblee, GA.

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.

Some of the cited violations:

Hazard Analysis and Risk-Based Preventive Controls Violations:

The firm did not identify and implement preventive controls adequate 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 or misbranded.

The firm manufactures ice cream, a ready-to-eat (RTE) product that is exposed to the environment prior to packaging, where it may be contaminated with environmental pathogens such as Listeria monocytogenes. The packaged ice cream does not receive a lethal treatment or otherwise include a control measure that would significantly minimize the pathogen, which is not killed by freezing temperatures.

FDA’s inspection included the collection of environmental swabs on June 22, 2021, during the production of RTE vanilla ice cream, and found that 8 of 85 swabs were positive for Listeria monocytogenes. Of the positive findings, one swab was collected from an area adjacent to food-contact surface where RTE ingredients were being prepared on the filling table. 

Whole genome sequencing (WGS) was conducted on the Listeria monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the 17  isolates comprise 3 different strains of Listeria monocytogenes.

Of particular significance, 14 isolates derived from the environmental samples collected at their facility during the FDA’s 2021, 2018, and 2017 inspections were genetically identical, representing a single strain of Listeria monocytogenes. Additionally, the 14 isolates were also genetically identical to 3 environmental swabs collected by the Georgia Department of Agriculture during a 2016 inspection of the facility. The presence of the same strain of L.isteria monocytogenes over multiple years is indicative of a resident pathogen or harborage site in the facility since 2016. 

Current Good Manufacturing Practice (Subpart B):

  1. The firm’s plant was not constructed in a manner that drip or condensate from fixtures, ducts, and pipes does not contaminate food, food-contact surfaces, or food-packaging materials. Specifically, throughout the inspection FDA investigators observed condensate on the ceiling in the (redacted) room located directly over production equipment, the (redacted) sink, and prep tables.
  2. The plumbing was not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant. Specifically, the employee hand washing sink located in the processing area, beside the back employee doorway, drains directly onto the floor. FDA investigators observed water from this sink flow across the floor in a heavy foot traffic area, away from the floor drain.
  3. The firm did not provide adequate ventilation and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces. Specifically, FDA investigators observed the ceiling vent located above the prep table in the kitchen to have a heavy accumulation of dust and debris.
  4. The company did not properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests. Specifically, on June 23, 2021, FDA investigators observed accumulated retired and in-use equipment, storage racks, wooden pallets, milk crates, metal pans, and stainless-steel pipes stored behind the plant. Additionally, a door leading to the processing area was observed open for extended periods of time and flying insects were observed within the facility during the inspection.

The FDA will verify the adequacy of these corrective actions during their next inspection.

The full warning letter can be viewed here.

HK Produce Group Inc. DBA Y2S Trading Inc.
Long Island City, NY

An import company in New York is on notice from the FDA after an inspection was initiated based on FDA samples finding Listeria monocytogenes in four entries of fresh enoki mushrooms,

In a Jan. 5 warning letter, the FDA described an Aug. 11-25, 2021, Foreign Supplier Verification Program (FSVP) inspection of HK Produce Group Inc. DBA Y2S Trading Inc. in Long Island City, NY.

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 as required. Specifically, they did not develop an FSVP for any of the foods they imported, including each of the following foods:

  o Fresh enoki mushrooms imported from (redacted) located in the (redacted)

  o Fresh enoki mushrooms imported from (redacted) located in the (redacted)

  o Fresh enoki mushrooms imported from (redacted) located in the (redacted).

The full warning letter can be viewed here.

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