Mr. Jose Francisco Cintron-Santini
- Granja Cintron
Barrio Tomas de Castro #1
Road 788, Km. 4.5
- Issuing Office:
- San Juan District Office
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San Juan District
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500
April 4, 2017
17-SJN-WL-04 / CMS # 511394
UNITED PARCEL SERVICE
NEXT DAY DELIVERY – SIGNATURE REQUIRED
Mr. Jose Francisco Cintron-Santini, Owner
Barrio Tomas de Castro #1
Road 788, Km. 4.5
Caguas, Puerto Rico 00725
Dear Mr. Cintron-Santini:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Road 788, Km 4.5, Caguas, Puerto Rico, during September 19 through October 21, 2016. During the inspection, FDA found that your facility had serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell Eggs During Production, Storage, and Transportation of Shell Eggs 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.
Our investigators’ observations were noted on Form FDA 483, Inspectional Observations, issued and discussed with you on October 21, 2016. You may find the Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at http://www.fda.gov/
Your significant violations are as follows:
1) You failed to have a written Salmonella Enteritidis prevention plan (SE Plan) that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. Specifically, during the inspection you failed to provide our investigator with any records pertaining to your shell egg production. You also informed our investigators that you do not issue or retain any records pertaining to your egg farm operation.
2) You failed to have and implement procedures to ensure pullets are raised under SE monitored conditions, including environmental testing, as required by 21 CFR 118.4(a). Specifically, your firm failed to test the pullet environment for SE between 14 and 16 weeks of age as required by 21 CFR 118.4(a)(2)(i).
3) Your firm failed to conduct environmental testing for SE when your flock of laying hens reached 40-45 weeks of age as required by 21 CFR 118.5(a). Specifically, on October 17, 2016, you stated to our investigators that the first environmental sampling of the layers was performed on September 15, 2016, when the layers were approximately (b)(4). You did not perform environmental testing of the flock in House (b)(4) at the required interval (i.e., 40-45 weeks of age).
4) You failed to have adequate biosecurity measures to ensure that there is no introduction or transfer of SE into poultry houses as required by 21 CFR 118.4(b). Specifically:
a. You do not limit visitors on your farm as required by 21 CFR 118.4(b)(1). Our investigators observed visitors freely entering and walking into the process packaging facility located next to the entrance to House (b)(4). One visitor observed was a feed supplier who stated that he visits multiple farm locations. A second visitor was a retailer who stated he also visits multiple farms to make egg shell purchases. You stated to our investigators that the farm has no perimeter fencing and its only gate is always open.
b. You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses as required by 21 CFR 118.4(b)(2). You stated that the firm shares equipment among houses, but there is no cleaning and disinfecting procedure for the shared equipment.
c. You do not maintain practices that will protect against cross contamination when persons move between poultry houses as required by 21 CFR 118.4(b)(3). You stated visitors and employees may move around the farm’s premises, including moving from house to house and that they do not use any dedicated/special/limited clothing or shoes.
d. You do not take adequate steps to prevent stray poultry, wild bird, cats and other animals from entering poultry houses as required by 21 CFR 118.4(b)(4). On September 19, 2016, our investigators observed a white, wild bird eating from the hen’s feed, three (3) wild black birds standing on the ceiling beams, and lizards on the floor of House (b)(4). Our investigators also observed a laying hen out of its cage, standing on the manure pit. An employee informed the investigator that per the firm’s practice, the hen would be recaptured and returned to its cage in House (b)(4).
e. You do not maintain biosecurity measures prohibiting employees to keep birds at home as required by 21 CFR 118.4(b)(5). On September 19, 2016, two employees informed our investigators that management is aware that they raise and keep gamecocks at home.
5) Your firm failed to implement appropriate procedures to monitor for the presence of rodent, flies and other pests as required by 21 CFR 118.4(c). Specifically:
a. You do not monitor for rodents using appropriate monitoring methods and, when monitoring indicates unacceptable rodent activity within a poultry house, use appropriate methods to achieve satisfactory rodent control as required by 21 CFR 118.4(c)(1). Further, you failed to set appropriate thresholds for determining acceptable rodent activity and likewise did not indicate corrective actions if those thresholds are exceeded. Our investigators observed small, green, poison bait blocks on the floor, at the end of some of the cage rows inside House (b)(4). The bait blocks are not enclosed in bait stations and secured with wiring. The bait blocks appear to be unmonitored or maintained and there is no recorded monitoring for signs of activity and replacement as needed.
b. You do not remove debris within the poultry house and vegetation and debris outside a poultry house that may provide harborage for pests as required by 21 CFR 118.4(c)(3). Specifically, on October 17, 2016, our investigators observed too numerous to count (TNC) carcasses of dead, decaying hens, piled at the end of hen cages in Row (b)(4) of Hen House (b)(4). According to an employee, the carcasses were piled starting October 15, 2016. Additionally, one of your houses had a pile of debris including cardboard boxes, egg trays, cables and tires that would serve as rodent harborage.
Without a threshold, such as rodent indexing, it is impossible to determine what an unacceptable level of rodent activity is. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity. See:
6) Your firm failed to hold eggs at or below 45°F ambient temperature beginning 36 hours after time of lay as required by 21 CFR 118.4(d). Our investigators observed that you do not monitor or document your walk-in cooler temperatures. On September 19 and 20, 2016, our investigators measured the ambient temperature of your firm’s cooler and found it to be (b)(4) and (b)(4), respectively. You explained that the (b)(4) and is also (b)(4). Additionally it was noted that your firm is closed (b)(4); therefore, (b)(4).
Your practice of powering off the (b)(4), combined with failing to measure and monitor temperature records indicates that there is no way for you to verify whether the cooler is being maintained at or below 45°F.
7) You failed to perform environmental testing for SE in the poultry house at four to six weeks after the end of the molting process, as required by 21 CFR 118.5(b). Specifically, during the inspection your employee informed our investigators that you (b)(4). As noted above, the first environmental sampling of the layers was performed on September 15, 2016, when the layers were approximately (b)(4).
8) Your eggs were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health within the meaning of Section 402(a)(4) of the FD&C Act. Specifically, on September 19, 2016, our investigators observed the following conditions and practices at your firm during the processing of shell eggs:
- Evidence of what appears to be rodent activity, rodent excreta pellets (droppings), rodent marks on floors and walls were found in the egg processing and packaging areas and inside the walk-in cooler. In addition, what appears to be rodent or pest excrement was observed on food contact surfaces, foam egg packaging containers, packaging cartons, walk-in cooler and packaging/processing area. Packaging and processing supplies were stored unprotected under filthy conditions in the poultry house. These conditions serve to harbor and foster harmful microbiological organisms and filth and may lead to contamination of shell eggs with these contaminants.
- Your firm’s employees were observed wiping their hands and foam egg cartons with a dirty rag without further cleaning before eggs are placed in them. Harmful microorganisms may remain viable on improperly cleaned and sanitized food contact surfaces, and these items may lead to contamination of the food which they come in contact.
- Too numerous to count fly eggs and fly larvae observed in inner wall and brush of egg cleaning machine. In addition, the egg washer machine interior walls, brush, and nozzles were observed with build-up materials like slime and mold growth. As noted above, harmful microorganisms may remain viable on improperly cleaned and sanitized food contact surfaces, and these items may lead to contamination of the food which they come in contact.
- Egg processing and packaging areas lack screening protection against pests. Investigators observed at least four lizards and one iguana on walls and floors in proximity to washed eggs, ready for distribution. These pests can carry and transfer pathogenic microorganisms and filth into the final egg washing area and can lead to cross-contamination of shell eggs processed in these areas.
- Our investigators observed filthy restroom facilities which lacked hand washing soap, hand sanitizer, hot water, paper towels or automatic dryers. In addition, your facility lacked required postings directing employees to wash and sanitize hands as appropriate prior to returning to processing areas. Human pathogens such as Salmonella, Hepatitis A, and Shigella spp. may be transmitted to foods by unwashed hands.
This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the FD&C Act, the PHS Act, and the shell egg regulation. You also have a responsibility to use/implement procedures or plans that will prevent further violations of applicable statutes and regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice; such as, seizure, injunction, or the initiation of administrative enforcement procedures as defined in 21 CFR Part 118.12, Enforcement and Compliance.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific action you have taken or plan to take to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
Your written response should be directed to the Food and Drug Administration, Attention: Maridalia Torres, District Director, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Carlos A. Medina at (787) 729-8617 or via e-mail at email@example.com
San Juan District