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 Royal Ice Cream Company Inc.
Manchester, CT
A food firm in Connecticut is on notice from the FDA for serious violations, including an environmental swab from the firm’s facility that found Listeria monocytogenes.
In a July 28, 2022, warning letter the FDA described a Jan. 19 through Feb. 22, 2022, inspection of The Royal Ice Cream Company Inc.’s ready-to-eat (RTE) manufacturing facility in Manchester, CT.
The FDA’s inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
1. 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.
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 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 firm’s hazard analysis for ice cream products, dated March 8, 2020, covers all ice cream products manufactured at their facility and indicates that “pathogens” require a preventive control during processing at various steps such as “ (redacted) / Packaging / Labelling”, “(redacted)”, and “Assembly” and that “Preventive sanitation, Environmental monitoring programs, GMPs” are the preventive control measures applied at these steps where RTE food is exposed to the environment. However, as evidenced by the multiple and repeat findings of L. monocytogenes in their production environment, the firm did not identify and implement preventive controls adequate to ensure that they are significantly minimizing or preventing the hazard of the environmental pathogen L. monocytogenes.
In addition, the firm’s hazard analysis did not identify pathogens at their processing step of “(redacted)” as requiring a preventive control because “Pathogens are unlikely to grow in the low temperature present in the freezer.” However, during the inspection, employees were observed transferring an RTE cookie dough sandwich sheet to the (redacted), where the ice cream sheet was cut into 4 oz. bars and was exposed to the environment prior to packaging. L. monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods, including RTE ice cream products, exposed to the environment at steps such as (redacted), and L. monocytogenes does not require growth to present a hazard.
FDA’s inspection included the collection of environmental swabs on Jan. 19, 2022, during production and found that 2 of 78 swabs were confirmed positive for L. monocytogenes. Of the positive findings, one swab was collected from the food-contact surface of a filler head where RTE ice cream was being dispensed into pint-sized finished packages and one swab was collected from the stainless-steel table where RTE ice cream sandwiches were being prepared. This was not the first time L. monocytogenes was found in environmental samples collected at their facility. In 2017, FDA detected L. monocytogenes in three environmental swabs, including two from areas adjacent to food-contact surfaces. Furthermore, in response to the FDA’s 2022 environmental sample findings and their voluntary recall initiated in February 2022, the Massachusetts Department of Public Health (MDPH) collected retail finished product samples which confirmed L. monocytogenes in one finished product sample of salted caramel ice cream.
Whole genome sequencing (WGS) was conducted on the following L. monocytogenes isolates obtained from the FDA environmental samples and the MDPH retail product sample, as follows:
- Two L. monocytogenes isolates obtained from FDA 2022 environmental sample 1167432;
- Three L. monocytogenes isolates obtained from FDA 2017 environmental sample 999084;
- One finished product sample isolate of (redacted) salted caramel ice cream manufactured by their firm on Jan. 12, 2022 and sampled at retail by the MDPH.
Additionally, the firm voluntarily submitted isolates from their own testing from the environment, product samples, and raw material ingredient samples to be whole genome sequenced and analyzed by FDA. Based on the results of the WGS analysis, the six isolates obtained by FDA and MDPH and their submitted isolates comprise three different strains of L. monocytogenes. Two of these strains of are particular significance, specifically, one strain is comprised of one isolate derived from the environmental sample collected in 2022 and one finished product sample isolate of (redacted) salted caramel ice cream. This strain was genetically identical to an environmental swab, ingredient samples, and product samples collected by their facility in Feb. 2022, March 2022, and April 2022, respectively; and genetically identical to one clinical isolate collected in 2021, which indicates this strain has the capability of causing human illness. A second strain, comprised of three isolates derived from the environmental samples collected at their facility during our 2022 and 2017 inspections, were genetically identical, representing a single strain of L. monocytogenes.
The detection of L. monocytogenes in finished products and reoccurring presence of L. monocytogenes in their facility are significant in that they demonstrate their sanitation procedures have been inadequate to effectively control pathogens in their facility to prevent contamination of food.
In response to current L. monocytogenes findings, the firm ceased production from Feb. 8, 2022, to April 13, 2022, and conducted a voluntary recall of three lots of ice cream on Feb. 1, 2022, which was subsequently expanded on Feb. 11, 2022, to include all products within expiry.
2. The firm’s sanitation controls did not ensure that their 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, as required.
During the inspection on Jan. 19, 2022, employee practices that could lead to cross-contamination of food-contact surfaces were observed at various steps during the manufacturing of ice cream products, as follows:
a. Employees handled exposed RTE ice cream products with their gloved hands, touching the top non-food contact surface of table #(redacted), and then handled the food-contact surfaces of sheet pans without changing their gloves or washing and sanitizing their hands. FDA environmental sample INV1167432, swab 3, was collected from the top surface of table #(redacted) and was found to be positive for L. monocytogenes.
b. Employees (redacted) in-process RTE ice cream products at table #(redacted) in the packaging area by (redacted) via gloved hands. The employees then touched a trash barrel while placing (redacted) into the barrel, and then either submerged their gloved hands in (redacted) sanitizer or did not sanitize at all, before returning to their task of (redacted) and handling exposed RTE ice cream products. The employees did not change their gloves or wash and sanitize their hands after contacting the trash barrel when disposing of the (redacted).
c. An employee retrieved a mobile rack of in-process cookie dough sandwich sheets from the freezer by handling the non-food-contact surfaces of the rack and the freezer door handle with gloved hands. The employee did not change their gloves or wash and sanitize their hands before returning to their task of (redacted) and handling exposed RTE ice cream products at table #(redacted).
3. The firm did not establish and implement adequate written verification procedures for environmental monitoring, as required.
Specifically, they did not collect their environmental swabs at the frequency identified within their “Environmental Monitoring Procedures” dated Sept. 26, 2017. Their procedure stated, “(redacted) swabs are selected and (redacted),” and “(redacted).” However, they did not collect swabs at this frequency or follow the criteria as described by their procedure. For example, they collected a total of (redacted) swabs for the month on June 2, 2021, and all these swabs were collected from non-food-contact surfaces, two of which were noted as a retest from sample sites that were found positive for Listeria spp. on May 28, 2021. During the inspection, they indicated that swabs are routinely collected on a (redacted), and this was confirmed by review of their analytical records.
Supply-Chain Program (Subpart G)
1. The firm’s written supply-chain program does not provide assurance that a hazard requiring a supply-chain-applied control has been significantly minimized or prevented, as required.
Current Good Manufacturing Practice (Subpart B):
1. The firm 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, as required.
Specifically, on Jan. 19, 2022, during the processing of ginger ice cream lot (redacted), employees were observed using a high-pressure hose to rinse a stainless-steel pail and to spray the processing room floor, and overspray was aerosolizing immediately adjacent to uncovered flavor vats containing RTE (redacted), uncovered RTE ingredients on the production table, and near the food-contact surfaces of the filler in the ice cream production area. FDA collected environmental sample (redacted), swab (redacted), from the head of this filler and detected L. monocytogenes.
2. The firm’s 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, as required.
Specifically, on Jan. 19, 2022, the (redacted) (a food-contact surface) on their food tools (redacted) were observed to be damaged with cracks and missing plastic. They collected environmental swabs on this date and detected L. innocua on the (redacted) of this (redacted) and L. monocytogenes from the body of the (redacted).
3. The firm did not maintain their plant in a clean and sanitary condition, as required.
Specifically, on Jan. 19, 2022:
a. Dripping condensate was observed on the overhead pipe in the corridor outside of the walk-in freezer. This is a high foot traffic area, and employees move from the corridor to the RTE ice cream production and packaging area.
b. The freezer condensate drain line exits the freezer through the wall into the corridor. Moisture was observed on the floor underneath this condensate line. This is a high foot traffic area, and employees move from the corridor into the RTE ice cream production and packaging area.
The full warning letter can be viewed here.
Mexia Pallets LLC
San Juan, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 16, 2022, warning letter the FDA described an April 5-7, 2022, Foreign Supplier Verification Program (FSVP) inspection of Mexia Pallets LLC in San Juan, TX.
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 significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following foods:
- Persian limes imported from (redacted), located in (redacted)
- Apple soft drink imported from (redacted), located in (redacted)
- Orange soft drink imported from (redacted), located in (redacted)
The FDA also offered the following comments:
During the FDA’s most recent inspection, investigators noted the firm may qualify as a “very small importer.” If they meet the definition, they are still required to follow FSVP requirements. If they are a very small importer and they choose to comply with the modified requirements, they must document that they meet the definition of very small importer on an annual basis as required.
The full warning letter can be viewed here.
Blue Stone Import USA Inc.
Manhasset, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug.3, 2022, warning letter the FDA described a May 25 through June 6, 2022, Foreign Supplier Verification Program (FSVP) inspection of Blue Stone Import USA Inc. in Manhasset, 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 significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following foods:
- (Redacted) Spicy Chicken Flavor Ramen ((redacted)) from (redacted), located in (redacted)
- Wheat Flour from (redacted), located in (redacted)
The full warning letter can be viewed here.
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