As part of its enforcement activities, FDA issues warning letters to entities under its jurisdiction. Some letters are not released for public viewing until weeks or months after they are mailed. Business owners have 15 days to respond to the FDA warning letter. Warning letters are usually issued after the company has been given months to years to correct the problem.
The Royal Ice Cream Company
Manchester, CT
A Connecticut food company received FDA notice for serious violations, including environmental swabs of the company’s facilities
Warning on July 28, 2022 In the letter, the FDA describes an inspection of Royal Ice Cream Company’s ready-to-eat (RTE) manufacturing facility in Manchester, Connecticut, from January 19 to February 22, 2022.
FDA’s inspection found serious violations of current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Human Preventive Controls Food Regulation and resulted in the issuance of FDA Form 483. Major violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. The company has not identified and implemented adequate preventive controls to assure that any hazards requiring preventive controls will be significantly reduced or prevented, and its facilities manufacture, process, Food packaged or held will not be adulterated.
Their facility manufactures ice cream products, RTE foods that are exposed to the environment prior to packaging, where they may be contaminated with environmental pathogens such as Listeria monocytogenes. Packaged ice cream products are not lethally treated or otherwise contain control measures that can significantly reduce pathogens (eg, pathogen-lethal formulations).
The company’s hazard analysis for the following ice cream products, dated March 8, 2020, covers all ice cream products produced at its facility, noting that “pathogens” need to be Preventive control at each step of the )(REDACTED)” and “Assembly” and “Preventive Sanitation, Environmental Monitoring Programs, GMPs” are preventive controls applied at these steps of RTE food exposure to the environment. However, the company failed to identify and implement preventive measures sufficient to ensure that they significantly reduce or prevent harm from the environmental pathogen L. monocytogenes, as evidenced by the multiple repeated findings of L. control measures.
In addition, the company’s hazard analysis did not “Pathogens identified in steps” require preventive controls as “pathogens are unlikely to grow at low temperatures in refrigerators.” However, during inspections, employees were observed transferring RTE cookie dough sandwich slices to ice cream slices where the ice cream slices were cut. (REDACTED) into 4 oz. sticks and exposed to the environment prior to packaging. Listeria monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE ice cream products, in (REDACTED) and other steps exposed to the environment, while L. monocytogenes does not need to grow to be a hazard.
FDA inspections included environmental swabs collected during manufacturing on January 19, 2022, and found that 2 of 78 swabs were confirmed positive for L. monocytogenes. In the positive result, one swab was collected from the food contact surface of the filling head, where RTE ice cream was dispensed into pint-sized finished packages, and the other was collected from a stainless steel table , where RTE ice cream sandwiches are being filled. Ready. This isn’t the first time Listeria monocytogenes has been found in environmental samples collected at their facility. In 2017, the FDA detected Listeria monocytogenes in three environmental swabs, two from areas adjacent to food contact surfaces. Additionally, in response to the FDA’s 2022 environmental sample findings and its voluntary recall initiated in February 2022, the Massachusetts Department of Public Health (MDPH) collected retail finished samples that confirmed the presence of a salted caramel ice cream sample in a finished sample. Listeria monocytogenes is present.
Whole genome sequencing (WGS) was performed on the following L. monocytogenes isolates obtained from FDA environmental samples and MDPH retail product samples, as follows:
In addition, companies voluntarily submit their own tested isolates from the environment, product samples, and raw material component samples for whole-genome sequencing and analysis by the FDA. Based on the results of the WGS analysis, the six isolates obtained by the FDA and MDPH and their submissions included three different L. monocytogenes strains. Two of the strains are of special interest, specifically, one strain from an isolate from an environmental sample collected in 2022 and one (redacted) sample of the finished product Isolate Salted Caramel Ice Cream. This strain is genetically identical to environmental swabs, component samples, and product samples collected at its facility in February 2022, March 2022, and April 2022; and is genetically identical to one clinical isolate collected in 2021 , suggesting that this strain has the ability to cause disease in humans. The second strain consisted of three isolates that were genetically identical and represented a single strain of Listeria monocytogenes extracted from environmental samples collected at their facility during our inspections in 2022 and 2017 .
The importance of detecting L. monocytogenes counts in finished products and recurring L. monocytogenes in their facilities as they demonstrate inadequate sanitation procedures to effectively control pathogens in its facilities to prevent food contamination.
In response to the current L. monocytogenes finding, the company discontinued production from February 8, 2022 to April 13, 2022, and voluntarily recalled on February 2 Made three batches of ice cream. . 1, 2022, subsequently expanded on February 11, 2022 to include all expiring products.
2. The company’s sanitation controls failed to ensure that its facilities maintained adequate sanitation to significantly reduce or prevent hazards from employee handling, such as environmental pathogens and biohazards.
During the inspection on January 19, 2022, during various steps in the ice cream product manufacturing process, employee behaviors that could lead to cross-contamination of food contact surfaces were observed as follows:
One. Employee handles exposed RTE ice cream product with gloved hands, touching the top non-food contact surface of the table#(REDACTED), then Handle food-contact surfaces of pans without changing gloves or washing and sanitizing hands. FDA Environmental Sample INV1167432, Swab 3, was collected from the top surface of Form #(REDACTED) and found L. monocytes hyperplasia.
b. Employee(redacted) Table#(redacted) by (REDACTED) wearing gloves in packing area. The employee then touched a trash can while placing (REDACTED) in the bucket and then dipped gloved hands into (redacted) sanitizer or no sanitizer at all, then return to their task(redacted) and handling exposed RTE ice cream products. Employee did not change gloves or wash and sanitize hands after touching trash can while handling (REDACTED).
C. An employee used gloved hands to handle the shelf’s non-food-contact surfaces and freezer door handle, removing a mobile shelf from the freezer that included a cookie dough sandwich sheet in the process. The employee did not change gloves or wash and sanitize hands at table before returning to (REDACTED) tasks and handling exposed RTE ice cream products# (REDACTED).
3. The company did not establish and implement appropriate written verification procedures for environmental monitoring as required.
Specifically, they did not collect environmental swabs at the frequency identified in their “Environmental Monitoring Procedures” dated September 26, 2017. Their program states, “(edited) swab is selected, and (edited)” and “(REDACTED)”. However, they did not collect swabs at this frequency, nor did they follow the standards described in their procedure. For example, they collected a total of (REDACTED) swabs during the month of June 2, 2021, all from non- Food contact surfaces, two of which were recorded as retests at sample points positive for Listeria. On May 28, 2021. During the inspection, they stated that swabs were regularly collected on (redacted) and this was confirmed by reviewing their records of analysis.
Supply Chain Planning (Subsection G)
1. The company’s written supply chain plan does not guarantee that hazards requiring supply chain application controls have been significantly reduced or prevented as required.
Current Good Manufacturing Practices (Subpart B):
1. The company is not required to conduct all food manufacturing, processing, packaging and preservation under the conditions and controls necessary to minimize the potential for food contamination.
Specifically, January 19, 2022 in the Ginger Ice Cream Batch (redacted) , employees were observed using high pressure hoses to flush stainless steel buckets and spray the floor of the process room, overspray in the immediate vicinity of the RTE (REDACTED) near uncovered seasoning barrels, RTE ingredients on uncovered production benches, and near food contact surfaces of the filling machine in the ice cream production area. Environmental samples collected by FDA (redacted) , swabs (redacted) , L. monocytogenes was detected from the head of the filler.
2. The design, materials and workmanship of the company’s equipment and utensils were not adequately cleaned, nor maintained as required to prevent contamination.
Specifically, on January 19, 2022, the (redacted)
on their food kit (food contact surface) (redacted) was observed to have cracks and lack of plastic damage. They collected environmental swabs on this day and tested on this (REDACTED) to L. innocua (edited) and from (edited) mononuclear in vivo Listeria cytogenes.
3. The company did not keep the factory clean and hygienic as required.
Specifically, January 19, 2022:
a. Condensed water droplets observed on overhead piping in corridor outside walk-in freezer fall. This is a high-traffic area, with employees moving from the hallway to the RTE ice cream production and packaging area.
b. The freezer condensate drain runs from the freezer through the wall into the hallway. Moisture was observed on the floor below this condensation line. This is a high-traffic area, with employees moving from the hallway to the RTE ice cream production and packaging area.
The full warning letter can be viewed here.
Mexia Pallets LLC
San Juan, Texas
An import company in Texas was unable to FSVP received notification from FDA.
In a warning letter dated August 16, 2022, the FDA described the April 7, 2022 date of May 7, 2022, of Mexia Pallets LLC of San Juan, Texas Foreign Supplier Verification Program (FSVP) inspections.
FDA inspection revealed that the company did not comply with FSVP regulations and resulted in the issuance of FDA Form 483a. The major violations are as follows:
The company failed to develop, maintain and comply with the FSVP as required. Specifically, they do not have a FSVP for any food they import, including each of the following:
at (REDACTED Edit) imported from
Apple Soda(REDACTED), at (REDACTED)
FDA also provided the following comments:
During a recent FDA inspection, investigators noted that the company May qualify as a “very small importer”. If they meet the definition, they still need to comply with the FSVP requirements. If they are very small importers and they choose to comply with the revised requirements, they must certify annually as required that they meet the very small importer definition.
The full warning letter can be viewed here.
Blue Stone Import USA Inc.
Manhasset, NY
An import company in New York was charged for many imported foods without FSVP Notification to FDA.
In a warning letter dated August 3, 2022, FDA described the May 25 to June 6, 2022 The Supplier Verification Program (FSVP) checks Blue Stone Import USA Inc. in Manhasset, NY.
FDA inspection revealed that the company was not in compliance with FSVP regulations and resulted in the issuance of FDA Form 483a. The major violations are as follows:
The company failed to develop, maintain and comply with the FSVP as required. Specifically, they do not have a FSVP for any food they import, including each of the following:
Wheat flour from (REDACTED), at (REDACTED)
The full warning letter can be viewed here.
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