WARNING LETTER
Nestor Reyes Farm & Associates
MARCS-CMS 701874 —
August 21, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Nestor E. Reyes del Valle
Recipient Title
President
Nestor Reyes Farm & Associates
Rd. 956, Km 10.0, Bo. Guzman Arriba
Rio Grande
00745
Puerto Rico
Issuing Office:
Human Foods Program
United States
WARNING LETTER
August 21, 2025
CMS #701874
Dear Mr. Nestor E. Reyes del Valle:
On November 13-15 & 19, 2024, and December 6, 2024, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm and egg processing facility, where your shell eggs are washed and packed, located at Rd. 956, Km 10.0, Bo. Guzman Arriba, Rio Grande, PR 00745. During the inspection of your farm, FDA investigators observed serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation regulation (the Shell Egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR Part 118). At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your farm.
Based on FDA’s inspectional findings, we have determined that the shell eggs produced on your farm do not comply with the provisions of 21 CFR Part 118. Failure to comply with the provisions of 21 CFR Part 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the FD&C Act, the PHS Act and the Shell Egg regulation through links on FDA’s home page at www.fda.gov.
We received your response to the FDA-483 via email on December 20, 2024, which described corrective actions taken or planned by your farm. Based on our review of the inspectional findings and your response, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your farm.
Your significant violations are as follows:
Shell Egg Regulation (21 CFR Part 118)
1. You did not have and implement a written SE Prevention Plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. You did not have a written SE Prevention Plan for the approximate
(b)(4)
layers on your farm. Your written response stated that an SE Prevention Plan would be finalized between December 2024 and January 2025. To date, we have not received a written SE Prevention Plan. You are required to have an SE Prevention Plan that includes, at a minimum, the SE prevention measures outlined in 21 CFR 118.4 (a) – (e), which include:
a.
Pullets
A written SE Prevention Plan must include, among other things, the required SE prevention measures relating to pullets. Under 21 CFR 118.4(a), these measures include procuring pullets that are SE monitored or raising pullets under SE monitored conditions. Under 21 CFR 118.4(a)(1), “SE monitored” means that chicks are procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan’s (NPIP) standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or an equivalent standard. Under 21 CFR 118.4(a)(2), “SE monitored” also means that the pullet environment is tested for SE when pullets are 14-16 weeks of age.
Your farm received a primary flock of
(b)(4)
chicks on April 30, 2024, followed by a secondary flock of
(b)(4)
chicks on May 7, 2024. We acknowledge you provided a NPIP Form for the flock of chicks you procured from your supplier on May 7, 2024, but you did not provide documentation for the chicks received on or around April 30, 2024. Furthermore, you did not conduct the required SE environmental test for both flocks at 14-to-16 weeks of age, as required by 21 CFR 118.4(a)(2)(i).
Your written response stated that you will schedule for future flocks to be tested for SE between 14-16 weeks of age by a licensed professional. However, as discussed above, we have not received a written SE Prevention Plan that describes these measures. We also note that your written response stated, as part of your firm’s corrective actions, that FDA swabbed poultry house
(b)(4)
on November 19, 2024, with subsequent negative results. The layers were approximately
(b)(4)
weeks of age when FDA conducted this sampling. This does not constitute a corrective action and should not be viewed as suc
h.
b.
Biosecurity
A written SE Prevention Plan must include, among other things, the required SE prevention measures relating to biosecurity, as stated in 21 CFR 118.4(b). That provision requires you to take steps to ensure that there is no introduction or transfer of SE into or among poultry houses. These biosecurity measures must include, at a minimum:
Limiting visitors on the farm and in the poultry houses (21 CFR 118.4(b)(1));
Maintaining practices that will protect against cross contamination when equipment is moved among poultry houses (21 CFR 118.4(b)(2));
Maintaining practices that will protect against cross contamination when persons move between poultry houses (21 CFR 118.4(b)(3));
Preventing stray poultry, wild birds, cats, and other animals from entering poultry houses (21 CFR 118.4(b)(4)); and
Not allowing employees to keep birds at home (21 CFR 118.4(b)(5)).
As discussed above, you did not have a written SE Prevention Plan to address these measures. Furthermore, visitors’ access to the facility was not limited and, despite your indication on November 13, 2024, that individuals enter the facility to pick up or distribute eggs every other day, our investigators identified August 20, 2024, as the last date a pickup was registered in your entry log. Additionally, for poultry house
(b)(4)
, FDA investigators observed there was no entry door to limit access and the house had damaged or missing netting and gaps within the cement structure. Numerous wild birds located inside the poultry house above layers in cages, in walkways, and eating directly from feed trays. Wild birds were also observed in the manure pits, and along the perimeter of your exposed house. Furthermore, cats and several species of reptiles were also observed in the manure pit and surrounding the poultry house.
We acknowledge your written response, in which you state you are now restricting visitor access to the farm through signs, and that you have implemented a visitor log and provided employee training. You also described how you will prevent stray animals from entering the poultry houses by adding physical barriers. You state your poultry houses are under construction, which you expect to be completed by June 2025. However, your written response lacks supporting detail to further assess how you will implement these corrective actions and practices. Additionally, you did not provide an SE Prevention Plan to describe any biosecurity steps.
c.
Rodents, Flies, and Other Pest Control
A written SE Prevention Plan must include, among other things, the required rodent, fly, and other pest control measures as stated in 21 CFR 118.4(c). As discussed above, you did not have a written SE Prevention Plan to address these measures. Furthermore, you were not monitoring for the presence of rodents and flies by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2), nor did you remove debris within a poultry house and vegetation and debris outside the poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3).
Specifically, for rodents, you stated you receive monthly services by a subcontractor; however, there were no pest control records available for review. Additionally, FDA investigators observed multiple rodent bait stations for poultry house
(b)(4)
that were broken and/or did not contain bait. For flies, you did not have any monitoring or control measures in place, and FDA investigators also observed flies too numerous to count inside the poultry house that were in direct contact with hens, eggs, and chicken feed. Furthermore, FDA investigators observed harborage for pests in and outside of your poultry house. This included excessive amounts of accumulated trash and debris, stagnant water, piles of broken eggs, and spilled chicken feed. Also, multiple deceased layers were observed inside poultry house
(b)(4)
, with two of the deceased birds having their heads in direct contact with the egg belt, causing the eggs to get jammed.
Your written response acknowledged that rodents were not being monitored appropriately and stated that the rodent monitoring and bait stations have been installed and updated, more rodent bait stations have been added around buildings, professional pest control services have been engaged, and that you have cleaned and removed debris that may attract rodents. Furthermore, your response acknowledged that the presence of flies was not being appropriately monitored and stated that fly monitoring systems have been updated. Additionally, you stated potential pest harborage sites inside and outside the poultry houses have been eliminated. However, your response did not provide an SE Prevention Plan or provide supporting details to assess whether the corrective actions were adequate. Please note that in addition to describing appropriate monitoring methods for rodents and flies, a written SE Prevention Plan must also address the requirement that when monitoring indicates unacceptable rodent or fly activity within a poultry house, you must use appropriate methods to achieve satisfactory rodent/fly control.
d.
Cleaning and Disinfection
A written SE Prevention Plan must include, among other things, cleaning and disinfection procedures for the poultry house, as stated in 21 CFR 118.4(d). You must clean and disinfect the poultry house according to these procedures before new laying hens are added to the house, if you have had an environmental test or an egg test that was positive for SE at any point during the life of a flock that was housed in the poultry house prior to depopulation.
As discussed above, you did not have a written SE Prevention Plan. Your written response states that you are developing a written SE Prevention Plan that will include, among other things, cleaning and disinfection protocols. However, as discussed above, you still have not provided a written SE Prevention Plan.
e.
Refrigeration
You did not hold eggs at or below 45°F ambient temperature beginning 36 hours after time of lay, nor do you have a written SE Prevention Plan including these refrigeration requirements, as required by 21 CFR 118.4(e). For example:
On November 14, 2024, your two analog thermometers located at the back and entrance of the cooler read
(b)(4)
°-
(b)(4)
°F, while FDA’s calibrated thermometer read 52°-58°F. On November 14, 2024, the same two analog thermometers read between
(b)(4)
°-
(b)(4)
°F, while the FDA calibrated thermometer read 58.8°F.
On November 15, 2024, your two thermometers at the entrance of the cooler read
(b)(4)
°F (digital) /
(b)(4)
°F (analog), while the FDA calibrated thermometer read 46.5°F.
On November 19, 2024, your two thermometers at the entrance of the cooler read
(b)(4)
°F (digital) /
(b)(4)
°F (analog), while the FDA calibrated thermometer read 51.9°F
We acknowledge your written response, in which you state that “
(b)(4)
.” You stated
(b)(4)
. However, your response did not provide an SE Prevention Plan or provide supporting details to assess whether the corrective actions were adequate.
2. You have never registered your egg farm with FDA, as required by 21 CFR 118.11(a).
Your written response states that you registered your farm with FDA by December 6, 2024; however, we do not have a record of your registration.
Federal Food, Drug, and Cosmetic Act (FD&C Act)
Your eggs were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health within the meaning of section 402(a)(4) of the FD&C Act. Specifically, during the inspection, our investigators observed the following insanitary conditions and practices at your farm during the processing of shell eggs:
FDA investigators observed too numerous to count dead flies inside the
(b)(4)
-gallon water tank of the egg washer and lying on the surface of the egg washer. Flies were also observed inside the packaging room on top of washed eggs.
The conveyor belt connecting poultry house
(b)(4)
to the egg washing/packaging room was uncovered, outside of any building structure. FDA investigators observed that the eggs held on this conveyor belt are continuously exposed to the environment and to pests and other animals, including flying insects, reptiles, cats, and wild birds, for up to
(b)(4)
hours (because collection and packaging operations are conducted every other day
).
Furthermore, you did not follow the disinfectant manufacturer’s instructions in preparing the disinfectant solution for the eggs by using the correct amount of disinfectant within the
(b)(4)
-gallon water tanks. You stated that
(b)(4)
oz. of disinfectant is used for the
(b)(4)
-gallon tank of the washing machine, instead of the 22.5 oz. directed by the manufacturer’s instructions of 0.5 oz per gallon.
Your written response stated that a monitoring program has been established to inspect conveyor belts and poultry houses daily. Furthermore, you stated your employees were not properly trained on the manufacturer’s instructions for the appropriate level of disinfectant. As your corrective actions, you state you have retrained your employees on the proper preparation of the disinfectant and revised your procedures and displayed them near the egg washer. Furthermore, your written response stated you have cleaned the washer, have implemented a daily cleaning and inspection schedule to ensure consistent hygiene, and introduced a new maintenance log for documenting cleaning and sanitation activities. You have not provided additional supporting details in order for us to fully evaluate these corrective actions.
This letter is not intended to be an all-inclusive statement of the violations that may exist at your farm or in connection with your shell eggs. 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 shell egg production practices are conducted in compliance with federal law, including the FD&C Act, the PHS Act, and the Shell Egg regulation.
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, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Additional Comment
Records are an important component to ensure your compliance with FDA’s Shell Egg regulation. 21 CFR 118.10 describes the records required for your SE Prevention Plan and other general recordkeeping requirements. We encourage you to review these requirements when working to develop and implement your SE Prevention Plan and environmental testing procedures. Please note that resources are also available on our website at www.fda.gov/eggs that address various aspects of shell egg regulation, including some of the topics addressed in this letter. For example, the December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” and the July 2015 Guidance for Industry “Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” provide answers to common questions about the Shell Egg regulation.
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 you have complied with pertinent laws and regulations, include your reasoning and any supporting information for our consideration.
Please send your reply via email to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Lisa Thursam, Compliance Officer, at Lisa.Thursam@fda.hhs.gov or by hardcopy to Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact Lisa Thursam, Compliance Officer, via email at Lisa.Thursam@fda.hhs.gov. Please include CMS reference #701874 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/
Maria S. Knirk, J.D., M.B.A.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Food and Drug Administration
Content current as of:
09/30/2025
Regulated Product(s)
Food & Beverages