Inspections, Compliance, Enforcement, and Criminal Investigations
Finca Cojobas, Inc. 10/11/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernández Juncos
San Juan, Puerto Rico 00901-3223
October 11, 2012
RETURN RECEIPT REQUESTED
RETURN RECEIPT REQUESTED
Mr. Mario Milanes
Finca Cojobas, Inc.
P.O. Box 847
Arecibo, Puerto Rico 00688
Dear Mr. Milanes:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Road 627 Km 4.2, Arecibo, Puerto Rico, on April 16 through May 4, 2012. 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 regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Failure to comply with the provisions of 21 CFR 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 http://www.fda.gov/.
Your significant violations were as follows:
- Your SE prevention plan failed to include a requirement that the pullets you procure be raised under SE monitored conditions, as required by 21 CFR 118.4(a); and you did not take steps to ensure that the pullets you procured were raised under SE monitored conditions. SE monitoring includes testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required under 21 CFR 118.4(a)(2)(i). Specifically, during the inspection, our investigator learned that you have no assurance that pullets purchased from (b)(6) and (b)(6) were SE monitored and SE clean. In addition, your firm does not have any supporting evidence to show that pullet environmental tests were performed on pullets at the age of 14 to 16 weeks.
Your revised SE prevention plan dated April 26, 2012, states that you will require that your pullet suppliers provide you with results of negative SE environmental results of the pullet environment when pullets are 14 to 16 weeks of age and that you will maintain these records for each of the flocks. FDA will verify this during our next inspection.
- Your SE prevention plan failed to include measures for limiting visitors on the farm, as required by 21 CFR 118.4(b)(1). Furthermore, while you do maintain a visitor’s log book, the investigator observed that on various occasions the feed delivery personnel were not noted in the log book, though they had made feed deliveries to your farm.
Your revised SE prevention plan dated April 26, 2012, includes measures for limiting visitors on the farm and states that you will maintain a visitor’s log. During our next inspection, we will verify implementation of these measures and that the visitor’s log is being accurately maintained.
- Your SE prevention plan failed to include procedures to monitor for rodents. Your SE prevention plan must address monitoring for rodents by visual inspection and mechanical traps or glueboards or another appropriate monitoring method, as required by 21 CFR 118.4(c)(1).
Your response received on May 22, 2012, contains a revised rodent monitoring form that contains columns for recording the number of live and/or dead rodents; and your revised SE prevention plan dated April 26, 2012, included with your response, states that you monitor for rodents by visual inspection, and that when monitoring indicates unacceptable rodent activity, you move up the date of your next pest service appointment and refill the bait stations. However, your April 26 revised plan does not define what level of rodent activity is considered unacceptable. Adequate rodent monitoring activities and accurate maintenance of rodent control records are key elements in assuring adequate rodent control at your egg laying facility.
- Your SE prevention plan failed to include procedures to monitor for flies. Your SE prevention plan must address monitoring for flies by spot cards, (b)(4) or sticky traps or another appropriate monitoring method, as required by 21 CFR 118.4(c)(2).
Your revised SE prevention plan dated April 26, 2012, states that you monitor for flies by visual inspection and that you place cardboard trays with insecticide in areas where fly activity is detected. It further states that when monitoring indicates unacceptable fly activity, you move up the date of your fly control service and increase the number of trays. However, your April 26 revised plan does not define what level of fly activity is considered unacceptable such that these corrective actions would be taken. Adequate fly monitoring activities and accurate maintenance of fly control records are key elements in assuring adequate fly control at your egg laying facility.
- You failed to hold and transport eggs at or below 45°F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). Specifically, during the inspection, investigators observed that the end of production occurred (b)(4) and the same shell eggs were kept at ambient temperature (b)(4). Your firm’s procedure is to collect eggs (b)(4).
Your revised SE prevention plan dated April 26, 2012, states that you will transport eggs in a refrigerated truck with a temperature of (b)(4). However, your April 26 revised plan does not include procedures for ensuring that your shell eggs are held at or (b)(4).
- Your SE prevention plan failed to include measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, and you failed to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, our investigators observed approximately four black birds inside (b)(4). Additionally, investigators noted that (b)(4) does not have a physical barrier to prevent wild birds, cats, or layer house.
We note that your response received on May 22, 2012, indicates that you will install (b)(4) in the next 6 months and that you have installed a gate at the bottom of the stairs to prevent dogs, cats, or other animals from gaining access to the egg laying houses. Your response also states that you have traps for dogs and cats. We will verify these corrective actions during our next inspection.
- You failed to remove debris within a 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, our investigators observed that you have stored construction material including wooden planks, wooden pallets, old tires, cardboard boxes, and other equipment next to the manure on the first floor of your (b)(4). Additionally, our investigators observed approximately 6 feet of old manure within the pit of your (b)(4). The pit area of (b)(4) is open to the outside environment and the bottom of the layer house floor is open to the manure pit. Investigators also observed vegetation on the east side perimeter of (b)(4) and debris stored in the north area of the first floor of this house.
We note that your response received on May 22, 2012, states that you have removed the vegetation from the east side of (b)(4). We will verify this corrective action during our next inspection. However, your response does not address the removal of the construction material that is stored underneath (b)(4) which according to your firm is to be used during construction of another poultry house on your premises. Your response also does not address the removal of manure that has been stored underneath your egg laying houses since you started operation in 2003. You have indicated that the manure has not been removed due to lack of authorization by the Junta de Calidad Ambiental (Puerto Rico Environmental Quality Department). We encourage you to work with this local government agency in order to address adequate manure removal from your premises. In the event of a positive environmental test result or a positive egg test result at any of your egg laying houses, you must comply with the cleaning and disinfection requirements under 21 CFR 118.4(d), which include removal of all visible manure.
- Your SE prevention plan failed to include practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). You also failed to maintain practices that will protect against cross contamination when persons move between poultry houses, as required by 21 CFR 118.4(b)(3). Specifically, our investigator observed that the foot baths located outside (b)(4) did not contain any disinfecting solution.
We note that your revised SE prevention plan dated April 26, 2012, describes your procedures for maintaining foot baths adequately and for requiring employees to use them before entering each laying house. We will verify the implementation of this procedure during our next inspection.
- You failed to perform environmental testing for SE in a poultry house when any group of laying hens constituting the flock within the poultry house was 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Specifically, during the inspection our investigators learned that you had not performed environmental testing of either of your (b)(4) environments since you started operations in 2003.
We note that your revised SE prevention plan dated April 26, 2012, indicates that you will conduct environmental sampling for the presence of SE in the production unit, but it does not indicate that the testing will be done during the time frames required in the egg rule. Additionally, your revised SE prevention plan does not provide details on your sampling plan or the methodology used to conduct the sample analyses. Please note that under 21 CFR 118.7(a), environmental testing must utilize a sampling plan appropriate to the poultry house layout. Furthermore, under 21 CFR 118.8(a), testing to detect SE in environmental samples must be conducted by the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” April 2008, or an equivalent method in accuracy, precision, and sensitivity in detecting SE. The adequacy of your sampling procedure, revisions to your SE prevention plan, and the methodology used to conduct environmental tests will be verified during our next scheduled inspection.
- You induced a molt in a flock but then 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, our investigators noted that you failed to environmentally test (b)(4) four to six weeks after the end of the molting process. The birds in (b)(4) were molted at (b)(4), and were (b)(4).
- You failed to comply with the record keeping requirements in 21 CFR 118.10 as follows:
- Your firm does not maintain records to document that pullets were SE monitored or raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2).
- Your firm does not maintain records documenting compliance with the refrigeration requirements, as required by 118.10(a)(3)(iv).
- Your written SE prevention plan was not stored on site, as required by 21 CFR 118.10(d).
- All required records do not have the signature or initials of the person performing the operation or creating the records, as required by 21 CFR 118.10(b)(3).
- All required records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production, as required by 21 CFR 118.10(c).
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 procedures to prevent further violations of these statutes and regulations.
In addition to the above violations, we also have the following comment:
Your firm’s revised SE prevention plan does not indicate the sampling plan to be used for conducting environmental samples or egg samples to comply with 21 CFR 118.7 or the testing methodology to be used for detecting SE in environmental or egg samples to comply with 21 CFR 118.8. We recommend that you revise your SE prevention plan to include a description of a sampling scheme that is appropriate to each of your poultry house layouts and a description of the testing methodology that will be used to detect SE in environmental and egg samples taken at your farm.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do 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 15 working days, you should explain the reason for your delay and the timeframe within which the remaining corrections will be completed.
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 under 21 CFR 118.12(a).
Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs mean all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be directed to the Food and Drug Administration, attention: Ms. 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, Compliance Officer, at (787) 474-9538 or via email at email@example.com.
San Juan District