Inspections, Compliance, Enforcement, and Criminal Investigations
Haciendas Morales dba Granja Avicola Morales 9/23/13
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
Telephone: 787-474-9500FAX: 787-729-6658
September 23, 2013
RETURN RECEIPT REQUESTED
RETURN RECEIPT REQUESTED
Mr. Samuel Morales Arce
Hacienda Morales dba Granja Avícola Morales
P.O. Box 858
Hormigueros, Puerto Rico 00660
Dear Mr. Morales:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at Road 404 Km 2.0, Moca, Puerto Rico, from April 24 through May 2, 2013. During the inspection, we 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 dated April 22, 2013, failed to include a requirement that pullets you procure be SE monitored, as required by 21 CFR 118.4(a); and you did not take steps to ensure that the pullets you procured were SE monitored, as also required by 21 CFR 118.4(a). In addition, you failed to maintain records to document that pullets were SE monitored or raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2). “SE monitored” means the pullets were raised under SE control conditions, including procuring chicks from SE monitored breeder flocks, as required under 21 CFR 118.4(a)(1) and 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, we learned that you have no assurance that pullets purchased from (b)(7)(C) and (b)(7)(C) were SE monitored. Form V 9-3 signed July 11, 2011, from (b)(4), USDA (United States Department of Agriculture), does not indicate that chicks were SE monitored. In addition, your firm does not have any documentation from (b)(7)(C) (from whom you procured your flocks at (b)(4)) to show that the pullet environment was tested for SE when the pullets were (b)(4).
Your firm’s May 13, 2013 response indicates that you plan to use a new supplier to ensure that you receive SE monitored pullets. We will verify this corrective action at our next inspection. However, your response is incomplete as you did not provide a revised SE Prevention Plan that includes specific measures to ensure that you procure pullets that are SE monitored. You also did not indicate or provide documentation to show that you are maintaining records to document that your pullets were SE monitored.
- You failed to implement your written SE Prevention Plan dated April 22, 2013 as required by 21 CFR 118.4. Specifically, you failed to monitor for rodents by an appropriate monitoring method, as required by 21 CFR 118.4(c)(1). In addition, you failed to maintain records documenting compliance with rodent monitoring and other rodent control measures, as required by 21 CFR 118.10(a)(3)(ii). Your firm’s SE Prevention Plan indicates you monitor for rodents by (b)(4). However, we did not observe rodent traps within the layer house and documentation of such monitoring was not provided during the inspection. Your SE Plan also indicates that you monitor for rodents by (b)(4). You stated during the inspection that your personnel monitor for rodents by (b)(4), but you did not provide any documentation of such monitoring.
We acknowledge that your May 13, 2013 response states that you will install (b)(4), and that you will monitor for (b)(4). We will verify this corrective action during the next inspection.
- You failed to implement the biosecurity measures in your written SE Prevention Plan dated April 22, 2013, as required by 21 CFR 118.4. Specifically, your SE Prevention Plan states that visitors and personnel entering the farm must sanitize their boots. However, investigators did not observe any footbaths to indicate that this section of your plan was being followed. Additionally, your plan indicates that all utensils, tools, and vehicles should be sanitized; however, there were no records documenting compliance with this biosecurity measure, as required by 118.10(a)(3)(i).
Your May 13, 2013 response indicates that you would (b)(4). These corrective actions and further implementation of your biosecurity plan (as well as implementation of the relevant recordkeeping requirements) will be verified during the next inspection.
- You failed to prevent wild birds from entering the poultry house as required by 21 CFR 118.4(b)(4). Specifically, we observed at least three wild birds inside the layer house, and the layer house does not have physical barriers to prevent wild birds, cats, or other animals from entering.
We reviewed your May 13, 2013 response, which states that you have obtained a price estimate (b)(4). We will evaluate the implementation of your correction during the next inspection.
- You failed to implement your written SE Prevention Plan dated April 22, 2013, as required by 21 CFR 118.4. In addition, you failed to maintain records documenting compliance with pest control measures, as required by 21 CFR 118.10(a)(3)(ii). Specifically, your plan states that you monitor for flies by conducting (b)(4). However, we did not observe any mechanical traps within the poultry house, such as the spot cards, glued strips, and scudder grills that are mentioned in your SE Prevention Plan. You also did not have documentation of any fly monitoring activities.
We acknowledge your May 13, 2013 response that indicates that you (b)(4). We will verify this corrective action during the next inspection.
- You failed to maintain records documenting your SE prevention measures as required by 21 CFR 118.10. Specifically, you do not maintain records documenting compliance with the shell egg regulation’s refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv). In addition, your SE Prevention Plan does not address the requirement that eggs be held and transported at or below 45°F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e).
We acknowledge your May 13, 2013 response, which stated that you monitor the temperature of your refrigerators, and that you have informed your suppliers about the refrigeration requirements and asked them to provide documentation relating to these requirements. In addition, you indicated that you monitor the temperature of the delivery trucks. However, your response did not include any records documenting compliance with the refrigeration requirements. Moreover, your plan does not include any specific details about your refrigeration practices. We will verify that you are keeping such records at our next inspection.
- You failed to maintain records documenting compliance with your environmental sampling procedures as required by 118.10(a)(3)(v). Your firm has a contract with a laboratory to perform the environmental sampling of your layer house (as well as the analysis of those samples). When asked by the investigators, you were unable to provide documentation concerning the sampling procedure this contract lab uses to conduct the SE environmental sampling of your layer house. Under 21 CFR 118.7(a), you must sample the environment using a sampling plan appropriate to the poultry house layout.
We acknowledge your May 13, 2013 response, which stated that your contract lab promised to send you the documents related to the procedure, but that they had not yet arrived. At our next inspection, we will verify that your sampling plan is appropriate to the poultry house layout, and that you are maintaining records documenting compliance with your environmental sampling procedures.
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 the responsibility to use procedures to prevent further violations of these 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 under 21 CFR 118.12(a).
In addition to the violations above, we have the following comment concerning our inspection:
- Although your SE Prevention Plan dated April 22, 2013 includes procedures to clean and disinfect your layer house prior to moving in a new flock, you could not provide documentation of cleaning and disinfection of your layer house prior to moving in your current flock in December 2011. We were therefore unable to determine if you have been implementing this aspect of your SE Prevent Plan as required by 21 CFR 118.4. We acknowledge your firm’s May 13, 2013 response, which states that you will clean and disinfect the hen house before bringing in a new flock and that you will keep a record of this.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps 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 15 working days, you should explain the reason for your delay and the timeframe within which remaining corrections will be completed.
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