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Royal Ice Cream Co, 27 Warren St, Manchester, CT 06040, United States
2 months ago
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... 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
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 studio movies grill kitchen has cockroaches. Employees eat in the kitchen while they prepare food. The kitchen is dirty. | Symptoms: Something else
Tonight my family and I decided to try this place in North Little Rock. After paying for my food I noticed that the food preparer or cook did not have on any gloves and was touching food without gloves on her hand which is very unsanitary she... said she was told not to wear gloves . so I asked for a refund before I even received any food and the young lady at the window went and got the same lady who made my food and she told me she did not have time to call the manager or the owner and worry them about this but she did have time to call the police and I did too this matter was handled very unprofessional and definitely very unsanitary I am very unsatisfied and I need a full refund and an apology. Store number 8047 ticket number 102. I left the store with no food and they kept my money.
November 7, 2022 at 06:55pm CST
while waiting for our order: Store #5450 on Highland—female worker pressing pizza dough in pan with her hands; she stopped got Pickup order for ShaMar while my husband was yet looking at menu trying to decide; afterwards, she got another pan... and started pressing dough down in it—she never washed her hands—I asked her did she just go from working cash register to pressing dough with her hands without washing her hands nor wearing anything: she said, “we all wash our hands plus the oven bakes at 500 degrees for 10 minutes..”
I was in awe to her reply. She asked if we were ready to place an order? But another man, Mr. Smith came to Pickup— I asked my husband to wait and let him pickup his order. My husband ordered, female received $20 and drop her large bill: then she gave my husband $2 change and she told him she had to go and get coins to give him change. They need a cashier! This (Female worker is working cash register, receiving cash money, then pressing down dough in pans and digging in her hair, digging in her ear; and proceeding to press dough again) I eye-witnessed the tall white coworker take out pizzas from oven: he back there digging in his nose rolling foreign contents between his fingers and rubbing it onto cardboard boxes and tipping all his germs into the cardboard that food goes into; and both his arms up to his elbows were inside boxes as he leans on prepping workstation and he had long straight hair and medium beard (no hair net nor beard covering) proceeded to put pizza and boneless chicken in a box.
(When female worker came back to the front counter and got a roll of dough and started pressing dough again. I expressed to her we did not want our pizza in the box the tall male coworker was leaning on—she picked up wrong box and fold it and trashed it. She turned her back to us told her tall male coworker something and she dug in her ear and started pressing dough in a pan. I was SO SICK to my stomach from what I kept eye-witnessing at this location—I asked my husband if we could leave? My husband who cannot speak very well due to 4 strokes and 3 heart attacks started to get up and leave—then, the tall white coworker that had been digging in his nose and rubbing foreign substance into the pizza cardboard brought us our pizza and box of boneless chicken after he had been digging in his nose..he had long straight hair past his shoulders without hair net nor beard covering brought our order to us with nasty hands after such unclean actions Moreover, this location needs to be investigated for cleanliness and need hair nets and beard coverings to be worn. Attached are pictures of the two employees that were performing such unclean actions during preparation of orders.. ..my stomach is Very Upset from seeing such actions—pictures are available ..this is Very Nasty—cannot eat!!!
I wasn't poisoned but bought a can of alphabet soup from there and the cans contents were spoiled (by bacterial from the smell). The can was brand new, unopened, undented, appeared completely normal, and the can was opened and tasted immediately after opening with a rotating wheel can opener.
Suspected food poisoning. Symptoms: Diarrhea,Cramps,Headache
Suspected source: Dinty moore beef stew
Onset: 1 day
Duration: 8 plus hour
Sick: 1 only I ingested it | Symptoms: Diarrhea, Cramps, Headache
Suspected food poisoning. Symptoms: Diarrhea,Nausea,Stomach Pain,Cramps
Suspected source: Cheese and tomato pannini
Onset: 3 hours
Duration: 24 hours
Additional information: Panini was cold in middle when arrived so took it back to he rectified | Symptoms: Diarrhea, Nausea, Stomach Pain, Cramps
i went with my nephew to get some food from there. i got a bag of fried pickle chips. i ate the entire bag. an hour later, im feeling sick to my stomach. i'm nauseous, i have diarrhea, and i threw up in my mouth. i don't know what's happened, but i can barely hold in water without gagging. | Symptoms: Nausea, Diarrhea, Vomiting, Other