WARNING LETTER
Corporacion Avicola Morovis Inc
MARCS-CMS 681668 —
July 24, 2024
Delivery Method:
VIA Electronic Mail
Reference #:
24-HAFE4-WL-03
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Juan De La Vega
Recipient Title
President
Corporacion Avicola Morovis Inc
PR-634 Km 2.2
Barrio Franquez
Morovis
00687
Puerto Rico
info@corpavicola.com
Issuing Office:
Office of Regulatory Affairs
United States
7/24/24
WARNING LETTER
24-HAFE4-WL-03 / CMS No. 681688
Dear Mr. De La Vega:
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 Road 634 Km 2.2, Morovis, Puerto Rico. During our inspection of your farm from January 11, 2024, through March 14, 2024, FDA investigators found 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). 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. We received your farm’s response letter dated March 22, 2024, to the FDA-483. In the letter, you stated that you hired a consultant to assist in evaluating your operations and that you plan to submit an action plan to FDA within 30 calendar days. We received your secondary response on May 16, 2024, and are issuing this letter to advise you of FDA’s continued concerns and to also provide detailed information describing the findings at your farm.
Your significant violations are as follows:
1. You did not have and implement a written Salmonella Enteritidis prevention plan (SE Prevention Plan) that includes, at minimum, the SE prevention measures required by 21 CFR 118.4.
a.
Biosecurity
You did not take steps 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 biosecurity program within your SE Prevention Plan dated May 2, 2023, addressed corrective actions in response to finding birds or other animals, but did not address measures for preventing wild birds, stray poultry, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). On January 11, 2024, our investigators observed one wild bird flying across the laying hens’ cages on the top floor of poultry house
(b)(4)
. In addition, excrement from unidentified stray animals was observed on a walkway at the top floor of poultry house
(b)(4)
.
In response, farm employees removed the wild bird and conducted a visual inspection assessing for entry gaps and potential droppings. Your farm also requested an employee to clean/disinfect the floor of poultry houses
(b)(4)
with a broom and spray a quaternary solution. However, these corrective actions alone are not adequate to prevent additional wild birds or other animals from entering your poultry houses. Additionally, although your farm completed installation of double wire and vinyl mesh around each poultry house in 2023, it was not sufficient to prevent ingress areas for external animals within your poultry houses.
Your written response dated May 16, 2024, indicated that daily inspections inside and outside each poultry house will occur, which includes checking for breaks or openings larger than “1’ x ½’” and entry points for external animals. These daily inspections are reflected in your updated biosecurity program dated May 13, 2024. Despite these updates, we are concerned that the size of the openings may continue to present an ingress point to your poultry houses, given that some openings equal to or smaller than “1’ x ½’” may still provide an ingress opportunity to certain external animals.
b.
Rodents, Flies, and other Pest Control
1. You did not monitor for the presence of rodents by appropriate methods, and when monitoring indicated unacceptable rodent activity within a poultry house, use appropriate methods to achieve satisfactory rodent control, as required by 21 CFR 118.4(c)(1). Specifically, your rodent control program within your SE Prevention Plan dated May 2, 2023, did not establish a threshold for acceptable or unacceptable activity for bait consumption for
(b)(4)
stations located on the lower part of each of your poultry houses. Further, you did not identify corrective actions if unacceptable activity was observed. Your plan stated that
(b)(4)
. The consumption of bait blocks was documented by your pest control contractor on several service reports, but no corrective actions were documented or implemented to address the presence of rodents. For example, for house
(b)(4)
there was evidence of bait consumption of
(b)(4)
blocks documented on May 29, 2023, July 24, 2023, August 31, 2023, October 9, 2023, December 29, 2023, and January 15, 2024. Additionally, on January 11, 2024, our investigators observed what appeared to be rodent fecal pellets on the premises of house
(b)(4)
in between the rodent stations
(b)(4)
but this data was not documented on your daily visual inspection logbook, as required by your SE Prevention Plan.
In your response dated May 16, 2024, you provided an updated plan and indicated that you have
(b)(4)
internal rodent traps per poultry house and that by using the results of the daily inspections, you will determine the type of infestation on a weekly basis through a calculation. However, your rodent index calculation (i.e., the number of rodents divided by the bait quantities, multiplied by the bait quantities divided by seven) for determining the level of infestation does not appear to have a scientific basis. Specifically, the "bait quantities" on the denominator and numerator cancel each other out so the formula represents the number of rodents divided by seven. Further, your plan does not clearly identify a threshold when corrective actions should be taken, and instead merely states that “[c]orrective actions will be defined according to the type of disinfection obtained.”
2. You did not implement your fly monitoring procedure and did not take appropriate corrective actions when monitoring indicated unacceptable activity, as required by 21 CFR 118.4(c)(2). Specifically, you did not take appropriate actions in regard to the presence of small flies on the sticky tapes. Your SE Prevention Plan dated May 2, 2023, stated
(b)(4)
sticky tapes were placed per house and tapes were counted
(b)(4)
per week. Your plan further stated if
(b)(4)
or more flies were observed, the affected areas will be fumigated, if necessary. During the inspection small flies, too numerous to count, were observed on one sticky tape located at the
(b)(4)
of house
(b)(4)
, one sticky tape located at the
(b)(4)
near Column #
(b)(4)
of house
(b)(4)
, on two sticky tapes located at the back of house
(b)(4)
, and two sticky tapes located in the walkway between
(b)(4)
of house
(b)(4)
. The presence of these flies exceeded your
(b)(4)
-count threshold. However, no corrective action had been taken. Further, during the current inspection it was your practice to apply Permethrin
(b)(4)
% in and around the houses on a
(b)(4)
basis as a control measure, regardless of the number of flies found on the sticky tapes. However, the pesticide label indicated that the product should not be used more than once every two weeks on areas where food, feed, and water are present.
In your response dated May 16, 2024, you provided an updated SE Prevention Plan that calls for
(b)(4)
-gallon fly trap bags per poultry house. You indicate that
(b)(4)
. However, this corrective action alone is not an appropriate method to achieve satisfactory fly control, as you are not taking sufficient corrective actions within the poultry houses to control the presence of flies. Further, your plan does not detail the frequency of your monitoring and does not indicate whether the
(b)(4)
flies is per bag or per house.
3. You did not remove debris within poultry houses and vegetation and debris outside your poultry houses that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, our investigators observed spilled chicken feed around rodent traps and walkways on the second floor inside the poultry houses
(b)(4)
; at least three wild birds feeding from spilled feed and broken eggs below the conveyor belt connecting poultry houses
(b)(4)
; multiple bones of an unidentified animal on the grass next to poultry house
(b)(4)
; liquid manure with puddles of stagnant water in the manure pits of all poultry houses; and overgrown vegetation around the premises of poultry house
(b)(4)
. Your SE Prevention Plan dated May 2, 2023, stated that all areas around the houses will be inspected to ensure that there is no accumulation of debris, overgrown vegetation, leaks of organic matter, puddles of water, spilled chicken feed, and broken eggs, and describes the corrective actions to be implemented if these conditions are observed. However, you did not follow your established control measures nor implement corrective actions.
In your response dated May 16, 2024, you stated that the high vegetation adjacent to the poultry house was removed; feed spill will be cleaned after each feeding cycle; leaks in pipes, hoses, and other water sources were fixed; feeding equipment and conveyors will be inspected daily to identify potential spillage; and you hired new staff for daily inspections to ensure feed spills and cracked eggs are cleaned daily. FDA has previously communicated concerns with harborage in and around your poultry houses. Your corrective actions will be verified during the following 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 FDA’s egg safety rule.
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).
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.
Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, Program Division Director, HAFE4, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernández
Program Division Director
Office of Human and Animal Food Operations-
East IV Division
Content current as of:
07/30/2024
Regulated Product(s)
Food & Beverages