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  5. Robert G. Miller dba Granja Asomante - 711894 - 10/21/2025
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WARNING LETTER

Robert G. Miller dba Granja Asomante MARCS-CMS 711894 —

Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Robert G. Miller
Recipient Title
Owner & President
Robert G. Miller dba Granja Asomante

Road 569 Km 5.5 Interior
Orocovis 00720
Puerto Rico

Issuing Office:
Human Foods Program

United States

WARNING LETTER

October 21, 2025

CMS #711894

Dear Mr. Miller,

On April 15, 2025, through May 1, 2025, the United States Food and Drug Administration (FDA) conducted an inspection of your shell egg farm located at Road 569 Km 5.5 Interior, Orocovis, Puerto Rico, 00720. 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) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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 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.

At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the deviations found at your farm. We received your written response to the FDA-483 on May 20, 2025, describing corrective actions taken. 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 minimum, the SE prevention measures required by 21 CFR 118.4. As a shell egg producer with (b)(4) or more laying hens at your farm, who does not sell all of your eggs directly to consumers and who produces shell eggs for the table market, you are required to have an SE Prevention Plan that includes, at minimum, the SE prevention measures outlined in 21 CFR 118.4 (a) – (e). Your “(b)(4)” (hereafter refenced as SE plan), created on March 1, 2020, and further revised on August 3, 2023, is inadequate as it does not address all the required SE prevention measures and you are not fully implementing the prevention measures you have addressed, as follows:

a. Pullets
Your written SE plan did not address that chicks would be procured from SE-monitored breeder flocks that meet the National Poultry Improvement Plan's standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or an equivalent standard, as required by 21 CFR 118.4(a)(1). Further, you did not ensure the pullet environment was tested for SE when pullets were 14-16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). Specifically, your SE plan indicated (b)(4). Additionally, your SE Plan stated (b)(4), however, pullets placed in House #(b)(4), and House #(b)(4), were tested at 17 and 18 weeks, respectively.

Your written response stated you have a digital calendar to remind you of when SE samples must be collected, and that the observations related to sampling occurred “because of the logistics of the laboratories.” Your response is unclear as to whether this digital calendar is a corrective action to facilitate coordinating in advance with the laboratory, or whether this calendar existed at the time of the inspection. To the extent it is a corrective action, we will verify the implementation and adequacy of it during the next FDA inspection. Additionally, we note that NPIP offers multiple certification programs. In your revised SE Plan dated May 19, 2025, you state (b)(4); however the procedure does not specify that the SE-monitored breeder flocks must meet NPIP’s standards for “U.S. S. Enteritidis Clean” status (9 CFR 145.23(d)) or an equivalent standard, as described above.

b. Biosecurity
You did not take steps to ensure that there is no introduction or transfer of SE into or among (b)(4) houses, as required by 21 CFR 118.4(b). Specifically:

1) You did not maintain practices that will protect against cross contamination when persons move between (b)(4) houses, as required by 21 CFR 118.4(b)(3). Your SE plan (b)(4) and stated in part, (b)(4). Additionally, your plan stated (b)(4). However, during the current inspection, we observed that there was no (b)(4) at the entrance of House #(b)(4) for staff entering the (b)(4) houses from the egg collection room. Additionally, staff were observed stepping on the footbaths only for a few seconds when entering the collection room and crossing in between the (b)(4) houses instead of immersing in the solution for at least 60 seconds, per the disinfectant’s label instruction.

Additionally, your SE plan required (b)(4) and indicated (b)(4). However, from January 5, 2025, through April 13, 2025, you documented (b)(4), but there was no indication that the footbaths were refilled with the required disinfectant concentration.

Your written response included a revised SE plan, dated May 19, 2025, which states (b)(4). Your response also states (b)(4). We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

2) You did not prevent stray poultry, wild birds, cats, and other animals from entering (b)(4) houses, as required by 21 CFR 118.4(b)(4). Your SE plan (b)(4). Additionally, your SE plan indicated (b)(4). However, we observed the following wild birds and evidence of cats within your (b)(4) houses:

  • At least seven wild birds flying throughout the hen level of House #(b)(4) and one wild bird flying inside the hen level of House #(b)(4).
  • Apparent cat excrement approximately two feet away from the bottom egg conveyor belt inside House #(b)(4).

Further, your (b)(4) houses were observed to have multiple areas that were open and unsealed allowing for potential ingress points. These areas included gaps at the manure pit level due to damaged metal mesh for House #1, #2, and #5, in addition to damaged front rolling gates at House #(b)(4) and #(b)(4). Further, House #(b)(4) was observed to have a large rolling door open.

Your written response indicated (b)(4). Your revised SE plan, dated May 19, 2025, states (b)(4). FDA has previously communicated concerns with animals and wild birds in your (b)(4) houses. We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

c. Rodents, Flies, and Other Pest Control
1) You did not monitor for the presence of rodents by appropriate monitoring methods, and when monitoring indicated unacceptable rodent activity within a (b)(4) house, use appropriate methods to achieve satisfactory rodent control, as required by 21 CFR 118.4(c)(1). Specifically, your SE plan (b)(4), which we consider to be an inappropriate monitoring frequency. This frequency will not allow you to detect rodent (b)(4) in a timely manner or for you to (b)(4), as stated in your SE plan, (b)(4). Further, your SE plan required (b)(4). During review of your contracted pest control company records for the (b)(4) of the houses, (b)(4). It is unclear if you took corrective action in response to these findings or if your (b)(4), as required by your SE plan.

Your written response included a revised SE plan, dated May 19, 2025, indicating (b)(4). Additionally, based on the example monitoring form you provided, it appears (b)(4). We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

2) You did not remove debris within (b)(4) houses and vegetation and debris outside of your (b)(4) houses that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, your SE plan (b)(4). However, we observed the following:

  • Excessive cat feces adjacent to feed silos for House #(b)(4) and on the side of House #(b)(4)
  • Stagnant water with accumulated debris on the sides of House #(b)(4) and House #(b)(4)
  • Overgrown vegetation covering bait stations located around each (b)(4) house
  • Spilled chicken feed below the silos used for House #(b)(4)

Further, we observed that the manure pits for House#(b)(4), #(b)(4), #(b)(4), and #(b)(4) were filled with liquid manure and puddles of water all along the entire length of the pit. We are concerned with the condition of your manure pits, as manure should be kept as dry as possible to make it less attractive to flies (and other insects). Additionally, the debris surrounding your (b)(4) houses could serve as an attractant or harborage for pests, rodents, and other animals that are known vectors of pathogens.

Your written response stated (b)(4). Additionally, you stated (b)(4). We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

Federal Food, Drug, and Cosmetic Act (FD&C Act)
During the inspection, at least (b)(4) were observed inside the egg collection room. The (b)(4) were in direct contact with the portable carts and yellow trays used to transfer shell eggs to the processing site. These conditions are insanitary and render your shell eggs adulterated within the meaning of section 402(a)(4) of the FD&C Act. Your written response indicated that (b)(4). We will verify the implementation and adequacy of your corrective actions during the next FDA inspection.

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 Comments

  • Your SE plan, created on March 1, 2020, and further revised on August 3, 2023, (b)(4). Additionally, we acknowledge that your procedure indicates (b)(4). However, it is unclear if you are removing other organic matter from the house prior to disinfection (other than manure and feed) as part of your (b)(4) procedure. We encourage you to review your current SE plan and subsequent records to ensure this information is included. Further, we remind you that cleaning and disinfection requirements must occur 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 (b)(4) house prior to depopulation.
  • Your SE plan, created on March 1, 2020, and further revised on August 3, 2023, addressed (b)(4); however, there are no cleaning and disinfection measures when moving this shared equipment between houses. We note that your revised SE plan dated May 19, 2025, (b)(4); however we encourage you to review all shared equipment used on the farm and update your SE plan accordingly.
  • Your SE Plan, created on March 1, 2020, and further revised on August 3, 2023, does not address refrigeration requirements. You stated (b)(4). However, you did not provide any additional information to confirm how the eggs would be held or transported at or below 45F ambient temperature beginning 36 hours after time of lay in the event of a delay in collection operations. Despite your eggs being transferred on a daily basis, we encourage you to update your SE plan to incorporate steps to ensure the eggs are refrigerated (in accordance with the Shell Egg regulation) in the event that eggs are delayed in being sent to a processor.

Please note that resources are 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” addresses topics such as rodent monitoring, 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” provides 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 #711894 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Thomas Kuntz
Acting Deputy Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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