Royal Ice Cream Co, 27 Warren St, Manchester, CT 06040, United States
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The FDA released a warning letter for The Royal Ice Cream Company Inc. located at 27 Warren St., Manchester, CT 06040-6534 on July 28, 2022.
During the inspection from January 19 through February 22, 2022, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard
During the inspection from January 19 through February 22, 2022, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule). FDA collected environmental samples (i.e., swabs) from various areas in this processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in this facility. FDA have determined that the RTE ice cream products manufactured in this facility were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.
The serious deviations found at the facility are:
- Hazard Analysis and Risk-Based Preventive Controls:
1- This 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 L. monocytogenes. The packaged ice cream products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. The detection of L. monocytogenes in finished products and reoccurring presence of L. monocytogenes in this facility are significant in that they demonstrate their sanitation procedures have been inadequate to effectively control pathogens in this facility to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the hygienic practices necessary to control this pathogen. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites. Additionally, FDA has repeatedly detected Listeria innocua (L. innocua), a non-pathogenic Listeria species, in environmental samples collected from this firm during FDA inspections conducted in 2022, 2020, 2018, and 2017. The presence of Listeria species such as L. innocua suggests that conditions also are suitable for survival and/or growth of L. monocytogenes. Furthermore, in reviewing this facility’s environmental monitoring program, they have repeatedly found L. monocytogenes and Listeria spp. through their own testing from April 30, 2021, through January 19, 2022, from their RTE ice cream processing environment. During a regulatory meeting held with this firm on March 31, 2021, FDA communicated their concerns regarding operations of this firm, including deficiencies within their written food safety plan and environmental monitoring program.
2.- The sanitation controls did not ensure that this facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling.
3.- They did not establish and implement adequate written verification procedures for environmental monitoring.
- Supply-Chain Program: Their written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
- Current Good Manufacturing Practice:
1.- They did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food.
2.- Their equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not maintained to protect against contamination
Source: www.fda.gov
About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction."
The serious deviations found at the facility are:
- Hazard Analysis and Risk-Based Preventive Controls:
1- This 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 L. monocytogenes. The packaged ice cream products do not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. The detection of L. monocytogenes in finished products and reoccurring presence of L. monocytogenes in this facility are significant in that they demonstrate their sanitation procedures have been inadequate to effectively control pathogens in this facility to prevent contamination of food. Appropriate control of L. monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the hygienic practices necessary to control this pathogen. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites. Additionally, FDA has repeatedly detected Listeria innocua (L. innocua), a non-pathogenic Listeria species, in environmental samples collected from this firm during FDA inspections conducted in 2022, 2020, 2018, and 2017. The presence of Listeria species such as L. innocua suggests that conditions also are suitable for survival and/or growth of L. monocytogenes. Furthermore, in reviewing this facility’s environmental monitoring program, they have repeatedly found L. monocytogenes and Listeria spp. through their own testing from April 30, 2021, through January 19, 2022, from their RTE ice cream processing environment. During a regulatory meeting held with this firm on March 31, 2021, FDA communicated their concerns regarding operations of this firm, including deficiencies within their written food safety plan and environmental monitoring program.
2.- The sanitation controls did not ensure that this facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling.
3.- They did not establish and implement adequate written verification procedures for environmental monitoring.
- Supply-Chain Program: Their written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented.
- Current Good Manufacturing Practice:
1.- They did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food.
2.- Their equipment and utensils were not designed and were not of such material and workmanship as to be adequately cleanable and were not maintained to protect against contamination
Source: www.fda.gov
About FDA Warning letters: "When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform the FDA of its plans for correction."
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