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.
Nara Company Ltd.
Ibusuki, Kagoshima, Japan
A food firm in Japan is on notice from the FDA for violations of various the FDA’s seafood Hazard Analysis and Critical Control Point (HACCP) regulation.
In a Feb. 7, 2023, warning letter, the FDA described a Sept. 7, 2022, FDA inspection of Nara Company Ltd.’s seafood processing facility in Ibusuki, Kagoshima, Japan.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483.
The significant violations are as follows:
1. The firm must conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, the firm’s revised HACCP plan does not list the food safety hazards of pathogenic bacteria growth and toxin formation, and metal inclusion. The seafood HACCP regulation requires that all reasonably likely food safety hazards be identified and that controls be in place through an adequate HACCP plan.
2. The firm must have a HACCP Plan that, at minimum, lists the critical limits that must be met. A critical limit is defined as “the maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s HACCP plan dated Sept. 19, 2022, for their seafood products, lists critical limits that are not adequate to control the identified food safety hazards. Specifically,
- The firm’s critical limits of (redacted) at the “(redacted)” critical control point are not adequate to control the hazard of unapproved aquaculture drugs. While FDA has approved the use of oxytetracycline on specific finfish and crustaceans, buri (Seriola quinqueradiata) is not one of the approved finfish.
- The firm’s critical limit of “(redacted)” at the “(redacted)” critical control point is not adequate to control the hazard of scombrotoxin (histamine) formation that is reasonably to occur during harvest, onboard the harvest vessel, and transit of the fish to the processing facility. To adequately control the food safety hazard of histamine, in addition to their critical limit for water tank temperature. FDA recommends that they include critical limits for:
i. Harvest vessel records or histamine testing; and
ii. Sensory examination;
iii. Internal temperature measurements; and
iv. Transit control.
- The firm’s critical limits of “(redacted)” to control the food safety hazard of Clostridium botulinum and “(redacted)” at the “(redacted)” critical control point to control the food safety hazard of undeclared allergens are inadequate. In addition to checking the incoming labeling for these declarations, their HACCP plan should include critical limits to ensure that the labels are properly applied to each package of finished product which is typically performed at the (redacted) step.
The full warning letter can be viewed here.
M. Fierro & Sons, LLC
Wilmington, DE
A food firm in Delaware is on notice from the FDA for violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
In a Jan. 19, 2023, warning letter, the FDA described a July 11 through Aug. 10, 2022, FDA inspection of M. Fierro & Sons, LLC’s ready-to-eat (RTE) hummus and cheese manufacturing facility in Wilmington, DE.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483.
The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls
1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). The firm’s food safety plan must also include the following:
1) The written hazard analysis;
2) The written preventive controls;
3) The written supply-chain program;
4) The written recall plan;
5) The written procedures for monitoring the implementation of the preventive controls;
6) The written corrective action procedures; and
7) The written verification procedures.
However, the firm did not have a food safety plan with any of the required elements. For example, the firm did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control.
Also, they did not identify and implement preventive controls 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. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.
The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:
a) The firm did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether bacterial pathogens are a hazard requiring a preventive control in their RTE hummus products. Their facility manufactures (redacted), which uses as ingredients (redacted). These ingredients have been associated with vegetative bacterial pathogens such as Salmonella.
A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing. Process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly minimize or prevent the hazards. These controls must be validated.
The firm does not have adequate controls in place for the hazard of bacterial pathogens, as evidenced by the following observations during the inspection:
i. On July 13, 2022, their operator mixing and cooking RTE (redacted) ingredients in an industrial mixer stated that the hummus is typically mixed and cooked for (redacted), but the temperature of the mixture is not checked or recorded, and the equipment does not have a built-in thermometer.
ii. On July 13, 2022, upon the FDA investigators’ request, their operator mixing and cooking RTE (redacted) ingredients in an industrial mixer used a thermometer to take the temperature of the hummus when the mixing and cooking was complete. The thermometer was observed to reach (redacted) at the end of the mixing and cooking step. The firm subsequently decided to dispose of the batch.
b) The firm did not identify and evaluate bacterial growth and/or toxin formation due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control. Their facility hot-packs their RTE hummus (e.g.,(redacted)) in 5-pound plastic tubs, which are (redacted) sealed with film, covered with plastic lids, and given a two-month shelf life (i.e., (redacted) packaging). The firm then place the 5-pound tubs of hummus in their walk-in cooler for cooling and finished product storage. Some of their hummus ingredients have been associated with pathogens (e.g., Salmonella in (redacted), and Clostridium botulinum in (redacted)). Vegetative and spore forming pathogens (i.e., that survive the cook step or are introduced after cooking) which are not cooled properly or otherwise time-temperature abused could grow (and produce toxins if applicable). Specifically, their RTE hummus is packed in (redacted) conditions, and Clostridium botulinum is an anaerobic bacterium which can grow and produce toxin in (redacted) conditions. A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial growth and/or toxin formation due to lack of time/temperature control as a hazard requiring a preventive control. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as refrigerating foods. Process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly minimize or prevent the hazards.
The FDA notes that they do not have adequate controls in place for bacterial growth and/or toxin formation because of lack of time/temperature control, as evidenced by the following observations during the inspection:
i. The firm did not monitor the cooling of their hot-packed 5-pound tubs of RTE hummus (e.g., (redacted)) in their walk-in cooler. Safe cooling to quickly remove heat from food is an important step to control growth of bacterial pathogens. Excessive time for cooling and lack of time/temperature control for safety (TCS) for foods has been consistently identified as one of the leading contributing factors to foodborne illness.
ii. The firm monitored the temperature of their walk-in cooler used to store hot-packed 5-pound tubs of RTE hummus (e.g., (redacted)) (redacted). This monitoring frequency does not provide assurance of time/temperature control throughout each processing day, at night, or over the weekend.
c) The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures RTE hummus products (e.g., (redacted)) which do not contain milk and RTE cheese products (e.g., ricotta and mozzarella) which contain milk (an allergen). They utilize equipment (e.g., stainless-steel bins that directly hold in-process foods, and an industrial-size drill with a bit for ingredient mixing) which can be shared between these two product categories. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label. FDA notes that they do not have adequate controls in place for allergen cross-contact as evidenced by the following observations during the inspection:
i. On July 13, 2022, an employee was observed manufacturing RTE (redacted). The employee (redacted) handled an unclean industrial mixing drill and touched a white residue adhered to it, which was stated to have been previously used in the RTE cheese production. The employee did not change gloves or wash hands before directly and (redacted) manipulating hummus ingredients and in-process product.
ii. On July 13, 2022, the recently cleaned (redacted) sealer used in the packaging of RTE (redacted) was observed to have small chunks of apparent cheese and a white residue adhered to it. In addition, chunks of food were observed on the cart holding the (redacted) sealer, from previous production runs of RTE cheese.
d) The firm did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control. Their facility manufactures RTE hummus (e.g., (redacted)) which is exposed to the environment after cooking prior to packaging. Their employees hand-pack the food and the packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the 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. In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control.
FDA notes that they do not have adequate controls in place for contamination with environmental pathogens regarding cleaning, monitoring procedures, and verifications activities, as evidenced by the following observations during the inspection:
i. On July 13, 2022, during production of RTE (redacted), an employee was observed in the dry storage room where they store bins for holding in-process ingredients. The employee handled the (redacted) ingredient bag with gloved hands, transferred (redacted) to an ingredient bin with a cup stored inside the bag, and returned the bin to the cleaned hummus packaging table. The employee did not wash or sanitize their hands or change or sanitize their gloves at any point. The employee also did not clean and sanitize the ingredient bin before placing it on the packaging table where RTE hummus is hand packed.
ii. On July 13, 2022, employees were observed using gloved hands to directly manipulate ingredients and in-process product and then using the same gloved hands to open doors, handle a hose, and clean the equipment and utensils. The same employees (without washing or sanitizing their hands or changing or sanitizing their gloves) then returned to direct hand-manipulation of ingredients, food-contact equipment, in-process product, packaging materials, and finished product during production of RTE hummus.
iii. On July 13, 2022, FDA investigators observed cleaning of utensils used to pack their RTE hummus. A utensil, a stainless-steel spoon used to pack hummus into 5-pound tubs, was cleaned and then dried with a paper towel, but was not sanitized prior to use. Food residue was observed on the utensil, and the utensil was not recleaned or sanitized prior to use in the process.
iv. The firm maintains a “Sanitation Checklist” used by their employees to monitor the sanitation of their facility (including food-contact surfaces of equipment and reusable totes and containers in “(reddacted)). On July 12, 2022, the firm’s vice president provided FDA with the “Sanitation Checklist” she reported was used to monitor the weeks of July 4 through 8, 2022, and July 11 through15, 2022. However, the document was completed for days that had not yet occurred. Specifically, the employee responsible for cleaning “(redacted)” had already signed off for cleaning through July 15, 2022, despite being on vacation since July 6, 2022. Furthermore, this sanitation monitoring document had already been signed off as reviewed by the vice president, despite the second week still being in progress.
v. During the inspection, FDA investigators found that the company performs periodic environmental swabbing of (redacted) and that they conduct that swabbing about (redacted). Environmental swabbing is intended to be a verification of the implementation and effectiveness of their sanitation preventive controls and the locations, frequency, and timing of the sampling is critical to determining that effectiveness. Moreover, FDA detected non-pathogenic Listeria species (Listeria spp.), in environmental samples collected from their facility. Specifically, FDA laboratory analysis of the environmental sample 1194658 collected on July 11, 2022 confirmed one (1) Listeria spp. positive swab collected from the floor near the wire slicer. The presence of non-pathogenic species of Listeria indicates that conditions are suitable for survival and/or growth of Listeria monocytogenes in the locations where they are found.
In the firm’s response dated Sept. 8, 2022, they provided a written food safety plan for their RTE hummus products. FDA has the following observations regarding their food safety plan:
a. Their hazard analysis identifies vegetative bacterial pathogens, such as Salmonella, as a hazard requiring a preventive control for (redacted) (an ingredient in (redacted)). Their hazard analysis states that they will control this hazard with a process control of (redacted). However, their critical limit of “(redacted)” does not clearly indicate a minimum value for temperature. Furthermore, their hazard analysis states that their corrective action procedure if their preventive control is not properly implemented is to “(b)(4)”. This procedure does not ensure that appropriate action is taken to identify and correct the problem or to reduce the likelihood that the problem will recur (see 21 CFR § 117.150(a)(2)(i-ii)). In addition, their sole verification activity for this preventive control is a “(b)(4).” However, this procedure does not ensure that their process monitoring instruments (e.g., thermometers) are calibrated or checked for accuracy (see 21 CFR § 117.165(a)(1)).
In addition, the firm’s hazard analysis evaluates vegetative bacterial pathogens in other shelf-stable ingredients (e.g., (redacted) and (redacted) in (redacted)) but concludes that the hazard does not require a preventive control because “Ingredients are only purchased from approved suppliers.” Supplier approval by itself does not verify that supplier control of the hazard is operating as intended on an ongoing basis.
b. The firm’s hazard analysis identifies “Growth of vegetative pathogens such as Salmonella and Listeria” as a hazard requiring a preventive control at the “Refrigerated Storage” step for finished product. They state they purchased “(redacted)” on Aug. 12, 2022, which has around-the-clock monitoring for their cooler. However, their food safety plan still does not address this hazard when cooling their 5-pound tubs of hummus after cooking. Simply putting food in a refrigerator may not be adequate to control pathogen growth and/or toxin formation during cooling. When large volumes and containers of hot food are cooled, it can take a long time to chill the food to a point where pathogen growth is appropriately inhibited. Furthermore, their hazard analysis states that their corrective action procedure if their preventive control is not properly implemented is to “(redacted).” This procedure does not ensure that appropriate action is taken to identify and correct a problem or to reduce the likelihood that the problem will recur. In addition, their verification activities for this preventive control are “(redacted).” This procedure does not ensure that their process monitoring instruments (e.g., thermometers) are calibrated or checked for accuracy.
c. The firm’s hazard analysis does not identify and evaluate allergen cross-contact as a known or reasonably foreseeable hazard to determine whether it requires a preventive control during processing of RTE hummus. Despite failing to identify the need for a preventive control for allergen cross-contact, the firm submitted in their written response an allergen procedure which requires color-coded yellow utensils for use only in hummus production.
d. The firm’s hazard analysis does not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for RTE hummus. The RTE hummus is exposed to the environment after cooking prior to packaging. The packaged food does not receive any further lethal treatment or other-wise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Despite failing to identify the need for a preventive control for environmental pathogens, they submitted in their written response a sanitation procedure. The stated purpose of the procedure is “Cleaning and sanitizing of the floor and non-food contact parts of equipment in the production area … to prevent establishment of environmental pathogens.” Sanitation controls must include (as appropriate to the facility and the food) procedures, practices, and processes for the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and for the prevention of cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product. Note that they are also required to establish and implement an environmental monitoring written procedure.
Current Good Manufacturing Practice
1. The firm did not maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated. Specifically, on July 13, 2022, during the manufacturing of RTE (redacted):
a. The skylight above the hummus production area was observed to be cracked with numerous holes in the glass. The plywood floor located directly below the skylight was covered with apparent water marks.
b. Floors throughout the production area for RTE hummus and cheeses were observed to be cracked with missing mortar between the bricks, making them difficult to clean. Standing water was observed at the entrance of the ricotta manufacturing area from the RTE hummus production area.
c. The ceiling above the RTE hummus production equipment and packaging area was observed to be cracked and stained with apparent water damage.
In addition, the firm did not clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. Specifically, on July 13, 2022, during the manufacturing of RTE (redacted):
a. Employees were observed rinsing the hummus production equipment with a hose, resulting in aerosolized overspray landing on the (redacted) sealer, including the film attached to a food-contact surface of the sealer. The sealer was only sprayed with water (i.e., not cleaned with detergent) and the film was not changed prior to its use in the packaging of RTE (redacted) that same day. Note that overspray and aerosols can transfer and spread pathogens from the environment to food-contact surfaces.
2. The firm did not conduct all food manufacturing, processing, packing, and holding operations under conditions and controls necessary to minimize the potential for contamination of food. Specifically:
a. On July 13, 2022, during production of the (redacted), employees were observed using a visibly unclean, general use box-cutter to cut open bulk pouches of RTE (redacted). The blade of the box-cutter contacted the (redacted).
b. On July 13, 2022, during the production of RTE hummus, an employee was observed retrieving (redacted) from a 40-pound bucket. The bucket was held in the storage area and an unknown black substance was observed on the side of the bucket. The exterior of the bucket was not cleaned and sanitized prior to use. Some (redacted) ran down the side of the bucket and fell into a measuring utensil.
c. On July 11, 2022, during production of RTE (redacted), a food grade (redacted), was (redacted). This chemical is not labeled for use in cheese production and as indicated on the chemical’s label, its use should always be followed with a potable water rinse. No rinse was performed of the RTE cheese after the application of the chemical and the chemical is not listed as an ingredient on the finished product label of their RTE cheeses.
The full warning letter can be viewed here.
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