WARNING LETTER
Loyd Sanabria Hernandez dba Avicola Santa Fe
MARCS-CMS 687540 —
December 17, 2024
Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Loyd Sanabria Hernandez
Recipient Title
Owner
Loyd Sanabria Hernandez dba Avicola Santa Fe
Barrio Aguirre Rd. 3 Km. 154
Salinas
00751
Puerto Rico
loydsan2000@gmail.com
Issuing Office:
Human Foods Program
United States
December 17, 2024
CMS No. 687540
Dear Loyd Sanabria Hernandez:
The United States Food and Drug Administration (FDA) inspected your shell egg farm and egg processing facility, where your shell eggs are washed, graded, and packed, located at Barrio Aguirre Rd. 3 Km. 154 Salinas, PR 00751. During our inspection of your farm from April 29, 2024, through May 15, 2024, FDA investigators found serious violations of the Prevention of Salmonella Enteritidis 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).
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 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 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. You provided a response on May 28, 2024, and supplemental responses on June 18 and 27, 2024. Your June 18 supplemental response included negative test results for Salmonella Enteritidis (SE) from environmental samples that you collected on June 13. However, based on our review of your responses and the inspectional findings, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your farm.
Your significant violations are as follows:
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. As further explained below, your document titled “Protocolo de Bioseguridad de Avicola Santa Fe-Medidas Sanitarias y Preventivas” (“plan”) is inadequate because it does not include all of the SE prevention measures required by 21 CFR 118.4. Further, you are not adequately implementing certain SE prevention measures you have established.
a.
Pullets
Your plan did not include requirements that procured pullets are SE-monitored or that pullets are raised under SE-monitored conditions, as required by 21 CFR 118.4(a)(1). Your plan also did not include requirements that the pullet environment will be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2). At the close of the inspection, hens within Ranch #1 were approximately 18 weeks of age, and those within Ranch #2 were approximately 51 weeks of age. Neither flock had been tested for SE at 14-16 weeks of age.
b.
Biosecurity
Your plan did not include adequate measures to ensure that there is no introduction or transfer of SE into or among poultry houses, as required by 21 CFR 118.4(b). Specifically, your plan did not include adequate measures to:
Limit visitors on the farm and within the poultry houses;
Maintain practices that will protect against cross contamination when equipment is moved among poultry houses;
Maintain practices that will protect against cross contamination when persons move between poultry houses;
Prevent stray poultry, wild birds, cats, and other animals from entering poultry houses; and
Not allow employees to keep birds at home.
Additionally, you did not implement certain biosecurity measures that were identified in your plan. For example, your plan indicates that a disinfection point is located at the entrance door to a poultry house and that it consists of a tray containing a cleaning and disinfection product. Staff must submerge the soles of their work boots in the tray before entering a poultry house. However, Ranch
(b)(4)
was not equipped with a tray containing this disinfectant. Further, the disinfectant for the footbath in Ranch
(b)(4)
was not monitored for efficacy. Your plan also states that you will clean and disinfect equipment on a weekly basis. However, such practices do not adequately protect against cross contamination when equipment is moved among poultry houses at a different frequency.
c.
Rodents, Flies, and Other Pest Control
You did not have written procedures for monitoring for the presence of rodents by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1). Further, you stated that you
(b)(4)
; however, you did not identify a threshold for acceptable and unacceptable rodent activity and did not identify corrective actions to take if unacceptable activity was observed.
You did not have written procedures for monitoring for the presence of flies by appropriate monitoring methods, as required by 21 CFR 118.4(c)(2). Further, you stated that your
(b)(4)
; however, you did not identify a threshold for acceptable and unacceptable fly activity and did not identify corrective actions to take if unacceptable activity was observed.
You did not remove debris within a poultry house and vegetation and debris outside your poultry house that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, investigators observed tall grass and weeds growing immediately around the poultry houses. Investigators also observed debris, including metal parts, wood pallets, and unused farm vehicles, near and next to the houses. Further, you did not have written procedures to address removal of debris and vegetation outside a poultry house.
d.
Cleaning and Disinfection
You did not have written cleaning and disinfection procedures for poultry houses, in the event that you have an environment test or egg test that was positive for SE at any point during the life of a flock, as required by 21 CFR 118.4(d). Your plan states generally that you will clean and disinfect after every flock. However, your plan does not address removing all visible manure and dry cleaning to remove dust, feathers, and old feed, as required by 21 CFR 118.4(d)(1)-(2). Further, your procedures lack specificity as to the disinfectants used.
e.
Refrigeration
You did not have written procedures indicating that eggs will be held or transported at or below 45°F ambient temperature beginning 36 hours after the time of lay, as required by 21 CFR 118.4(e). Specifically, your plan does not identify the temperature at which the eggs shall be refrigerated. Further, although your plan indicates that a log of the temperature at which the eggs are refrigerated would be kept, you did not maintain refrigeration records, as required by 21 CFR 118.10(a)(3)(iv).
2. You did not conduct environmental testing for SE in your poultry houses when laying hens were 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, your flock in Ranch
(b)(4)
was approximately
(b)(4)
weeks of age at the initiation of the inspection, but you did not conduct an environmental test when the flock was 40 to 45 weeks of age.
3. You do not have an active shell egg registration, as required by 21 CFR 118.11(a). Specifically, to date, your farm is not currently registered as an egg farm with FDA. Since your farm has
(b)(4)
or more laying hens, and at the time of the inspection was producing shell eggs for the table market and not selling all of the eggs directly to consumers, you must comply with the Shell Egg regulation’s registration requirement.
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 Act, the PHS Act, and the Shell Egg regulation.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If corrective actions cannot be completed within fifteen (15) working days of receipt of this letter, please state the reason for the delay and the timeframe within which the corrections will be completed. If you believe that you have complied with pertinent laws and regulations, include your reasoning and any supporting documentation for our consideration.
Please send your written response via email to Lisa.Thursam@fda.hhs.gov or to the U.S. Food and Drug Administration, Attention: Lisa Thursam, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement (HFS-607) at 5001 Campus Drive, College Park, MD 20740. Please reference #687540 on any submissions and within the subject line of any emails.
Sincerely,
/S/
Maria S. Knirk, J.D.
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/24/2024
Regulated Product(s)
Food & Beverages