WARNING LETTER
M. Fierro & Sons, LLC
MARCS-CMS 641400 —
January 19, 2023
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. William J. Meany
Recipient Title
Owner
M. Fierro & Sons, LLC
1025 N. Union Street
Wilmington
,
DE
19805-2752
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #641400
January 19, 2023
Dear Mr. Meany,
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) hummus and cheese manufacturing facility located at 1025 N. Union Street, Wilmington, DE from July 11, 2022 through August 10, 2022. During our inspection, 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), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings, we have determined that the RTE hummus and cheese products manufactured in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held un-der insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)].
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. You provided responses to the inspection on September 8, 2022 and September 19, 2022, describing corrective actions taken by your firm. After reviewing the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to pro-vide detailed information describing the findings at your facility. We also address your responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. You did not prepare, or have prepared, and implement a food safety plan, as required by 21 CFR § 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR § 117.126(a)(2). Your food safety plan must also include the following:
1) The written hazard analysis, as required by 21 CFR § 117.130(a)(2);
2) The written preventive controls, as required by 21 CFR § 117.135(b);
3) The written supply-chain program, as required by Subpart G;
4) The written recall plan, as required by 21 CFR § 117.139(a);
5) The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR § 117.145(a);
6) The written corrective action procedures, as required by 21 CFR § 117.150(a)(1); and
7) The written verification procedures, as required by 21 CFR § 117.165(b).
However, you did not have a food safety plan with any of the required elements. For example, you 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 your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)). Also, you 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 your facility will not be adulterated under Section 402 of the Act or misbranded under Section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). 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 (see 21 CFR § 117.135(c)). 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 (see 21 CFR § 117.140). You 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 (see 21 CFR § 117.160). Specifically:
a) You 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 your RTE hummus products. Your facility manufactures
(b)(4)
, which uses as ingredients
(b)(4)
. These ingredients have been associated with vegetative bacterial pathogens such as
Salmonella
.
A knowledgeable person manufacturing/processing food in your 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 (see 21 CFR § 117.135(c)(1)). Note that these controls must be validated as required by 21 CFR § 117.160.
You do 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, your operator mixing and cooking RTE
(b)(4)
ingredients in an industrial mixer stated that the hummus is typically mixed and cooked for
(b)(4)
, 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, your operator mixing and cooking RTE
(b)(4)
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
(b)(4)
at the end of the mixing and cooking step. You subsequently decided to dispose of the batch.
b) You 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. Your facility hot-packs your RTE hummus (e.g.,
(b)(4)
) in five-pound (5 lb.) plastic tubs, which are
(b)(4)
sealed with film, covered with plastic lids, and given a two-month shelf life (i.e.,
(b)(4)
packaging). You then place the 5 lb. tubs of hummus in your walk-in cooler for cooling and finished product storage. Some of your hummus ingredients have been associated with pathogens (e.g.,
Salmonella
in
(b)(4)
, and
Clostridium botulinum
in
(b)(4)
). Vegetative and sporeforming 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, your RTE hummus is packed in
(b)(4)
conditions, and
Clostridium botulinum
is an anaerobic bacterium which can grow and produce toxin in
(b)(4)
conditions. A knowledgeable person manufacturing/processing food in your 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 (see 21 CFR § 117.135(c)(1)).
We note that you do not have adequate controls in place for bacterial growth and/or toxin formation due to lack of time/temperature control, as evidenced by the following observations during the inspection:
i. You did not monitor the cooling of your hot-packed 5 lb. tubs of RTE hummus (e.g.,
(b)(4)
) in your 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. You monitored the temperature of your walk-in cooler used to store hot-packed 5 lb. tubs of RTE hummus (e.g.,
(b)(4)
)
(b)(4)
. This monitoring frequency does not provide assurance of time/temperature control throughout each processing day, at night, or over the weekend.
c) You did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Your facility manufactures RTE hummus products (e.g.,
(b)(4)
) which do not contain milk and RTE cheese products (e.g., ricotta and mozzarella) which contain milk (an allergen). You 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 your 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 (see 21 CFR § 117.135(c)(2)). We note that you 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
(b)(4)
. The employee
(b)(4)
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
(b)(4)
manipulating hummus ingredients and in-process product.
ii. On July 13, 2022, the recently cleaned
(b)(4)
sealer used in the packaging of RTE
(b)(4)
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
(b)(4)
sealer, from previous production runs of RTE cheese.
d) You 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, to comply with 21 CFR § 117.130(c)(1)(ii). Your facility manufactures RTE hummus (e.g.,
(b)(4)
) which is exposed to the environment after cooking prior to packaging. Your 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 your 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 (see 21 CFR § 117.135(c)(3)). In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). Note that if environmental monitoring is required, an environmental monitoring written procedure must be established and implemented and must meet the requirements in 21 CFR § 117.165(b)(3).
We note that you 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
(b)(4)
, an employee was observed in the dry storage room where you store bins for holding in-process ingredients. The employee handled the
(b)(4)
ingredient bag with gloved hands, transferred
(b)(4)
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 your RTE hummus. A utensil, a stainless-steel spoon used to pack hummus into 5 lb. 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. You maintain a “Sanitation Checklist” used by your employees to monitor the sanitation of your facility (including food-contact surfaces of equipment and reusable totes and containers in “
(b)(4)
. On July 12, 2022, your 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 “
(b)(4)
” 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 you perform periodic environmental swabbing of
(b)(4)
and that you conduct that swabbing about
(b)(4)
. Environmental swabbing is intended to be a verification of the implementation and effectiveness of your 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 your 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
L. monocytogenes
in the locations where they are found.
In your response dated September 8, 2022, you provided a written food safety plan for your RTE hummus products. We have the following observations regarding your food safety plan:
a. Your hazard analysis identifies vegetative bacterial pathogens, such as
Salmonella
, as a hazard requiring a preventive control for
(b)(4)
(an ingredient in
(b)(4)
). Your hazard analysis states that you will control this hazard with a process control of
(b)(4)
. However, your critical limit of “
(b)(4)
” does not clearly indicate a minimum value for temperature. Furthermore, your hazard analysis states that your corrective action procedure if your 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, your sole verification activity for this preventive control is a “
(b)(4)
.” However, this procedure does not ensure that your process monitoring instruments (e.g., thermometers) are calibrated or checked for accuracy (see 21 CFR § 117.165(a)(1)).
In addition, your hazard analysis evaluates vegetative bacterial pathogens in other shelf-stable ingredients (e.g.,
(b)(4)
and
(b)(4)
in
(b)(4)
) 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. Despite determining that a supply-chain preventive control is not required, you submitted in your written response a supply-chain procedure which includes a verification activity of checking the Certificate of Analysis for every receipt. It is unclear what testing is performed under such a Certificate of Analysis. In addition, if you verify control of vegetative bacterial pathogens in a raw material or other ingredient via a supply-chain program, note that
Salmonella
is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a writ-ten determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR § 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR § 117.430(b)(1)(ii)).
b. Your 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. You state you purchased “
(b)(4)
” on August 12, 2022, which has around-the-clock monitoring for your cooler. However, your food safety plan still does not address this hazard when cooling your 5 lb. 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, your hazard analysis states that your corrective action procedure if your preventive control is not properly implemented is to “
(b)(4)
.” 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 (see 21 CFR § 117.150(a)(2)(i-ii)). In addition, your verification activities for this preventive control are “
(b)(4)
.” This procedure does not ensure that your process monitoring instruments (e.g., thermometers) are calibrated or checked for accuracy (see 21 CFR § 117.165(a)(1)).
c. Your 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, you submitted in your written response an allergen procedure which requires color-coded yellow utensils for use only in hummus production. We will verify the implementation and adequacy of your allergen cross-contact controls during our next inspection, including the potential for milk allergen cross-contact associated with shared equipment which cannot feasibly be color-coded.
d. Your 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, you submitted in your 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 (see 21 CFR § 117.135(c)(3)). Note that you are also required to establish and implement an environmental monitoring written procedure (see 21 CFR § 117.165(b)(3)).
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR § 117.35(a). Specifically, on July 13, 2022, during the manufacturing of RTE
(b)(4)
:
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 your response dated September 8, 2022, you stated you are “investigating the best suitable options on fixing the skylight.” However, you did not provide a timeline for correcting the skylight and you did not state that you have ceased to produce food under the skylight. You should take immediate steps to protect food from contamination while you determine the best option to replace the skylight. You also stated you replaced the plywood under the skylight with red floor tiles and hired a masonry to replace bricks and grout throughout the plant. On September 19, 2022, you provided photographs demonstrating the floor repairs. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
In addition, you did not clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.35(a). Specifically, on July 13, 2022, during the manufacturing of RTE
(b)(4)
:
a. Employees were observed rinsing the hummus production equipment with a hose, resulting in aerosolized overspray landing on the
(b)(4)
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
(b)(4)
that same day. Note that overspray and aerosols can transfer and spread pathogens from the environment to food-contact surfaces.
In your response dated September 8, 2022, you stated you instructed your employee on cleaning and overspray. You also stated you had a chemical safety training meeting. However, you did not provide supporting documentation such as a training records for our review. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
2. You did not conduct all food manufacturing, processing, packing, and holding operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR § 117.80(c)(2). Specifically:
a. On July 13, 2022, during production of the
(b)(4)
, employees were observed using a visibly unclean, general use box-cutter to cut open bulk pouches of RTE
(b)(4)
. The blade of the box-cutter contacted the
(b)(4)
.
b. On July 13, 2022, during the production of RTE hummus, an employee was observed retrieving
(b)(4)
from a 40 lb. bucket. The bucket was held in the storage area and an unknown black sub-stance was observed on the side of the bucket. The exterior of the bucket was not cleaned and sanitized prior to use. Some
(b)(4)
ran down the side of the bucket and fell into a measuring utensil.
c. On July 11, 2022, during production of RTE
(b)(4)
, a food grade
(b)(4)
, was
(b)(4)
. 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 your RTE cheeses.
In your response dated September 8, 2022, you stated you had a meeting to correct GMPs on August 9, 2022; however, you did not provide any information regarding what was covered during the meeting or who attended. You also stated that all hummus materials are now kept separated in your hummus production room. In addition, you stated you have removed
(b)(4)
from the plant. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
In addition, we have the following comment regarding following directions or instructions for use on your cleaning and sanitizing chemicals. On July 13, 2022, during the manufacturing of RTE
(b)(4)
, an employee was observed dispensing approximately
(b)(4)
of
(b)(4)
cleaner into an orange five-gallon bucket. The employee then filled the bucket halfway with water and cleaned food-contact surfaces using the solution created in the bucket. The
(b)(4)
cleaner directions for use states to use “
(b)(4)
” and “
(b)(4)
.” The employee did not measure the concentration of the solution created in the bucket. The employee stated this was the normal procedure for mixing this cleaner solution. Following the instructions for use on a cleaning or sanitizing chemical’s label is important to ensure you achieve the correct concentrations and intended results.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to Compliance Officer Melissa B. Libby at U.S. Food & Drug Administration, 10 Waterview Blvd., 3rd Floor, Parsippany, NJ 07054. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact Melissa Libby by telephone at (973) 331-4997 or by email at melissa.libby@fda.hhs.gov.
Sincerely,
/S/
Robin M. Rivers
Acting District Director/Program Division Director
Philadelphia District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
robin.rivers@fda.hhs.gov
Content current as of:
02/28/2023
Regulated Product(s)
Food & Beverages