Farmer John Egg Enterprises, Inc. 7/19/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone (510) 337-6700
July 19, 2013
Mr. John W. Lewis, President
Farmer John Egg Enterprises, Inc.
5110 East Panama Lane
Bakersfield, CA 93307
Dear Mr. Lewis:
The United States Food and Drug Administration (FDA) inspected your shell egg production facilities located at 5110 East Panama Lane (Panama Ranch) and 6007 Cottonwood Road (Cottonwood Ranch), Bakersfield, CA on January 8 through 17, 2013. We found that both facilities had 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 118). Egg production at your farms must comply with all of the requirements of 21 CFR 118, which applies to farms where any of the eggs produced at the farm do not receive a treatment as defined in 21 CFR 118.3. 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 FFD&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 FFD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov.
We received your undated written response on February 7, 2013, concerning our investigator’s observations noted on the Forms FDA 483 (FDA 483), List of Inspectional Observations, which were issued to Mr. John Lewis at the close of both inspections. Our evaluation of your response is discussed below.
1. You failed to have and implement written SE Prevention Plans for your Panama Ranch and Cottonwood Ranch farms that include biosecurity measures for maintaining practices that protect against introduction of SE and cross contamination when equipment and people move among poultry houses, as required by 21 CFR 118.4(b)(2) and 21 CFR 118.4(b)(3).
We reviewed your response to the FDA 483 received on February 7, 2013. Your response included an amended written SE plan titled “FARMER JOHN EGG SE MONITORING AND CONTROL PLAN” last updated on January 28, 2013. Your amended SE Prevention Plan includes the use of (b)(4) disinfectants for use on equipment and shoes moving between laying hen age groups. We will evaluate the implementation of your updated SE plans including record keeping for this requirement during the next FDA inspection.
2. You failed to prevent wild birds from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, our investigator observed one wild bird in a poultry house at Panama Ranch and approximately 56 wild birds in five poultry houses at Cottonwood Ranch. Although your SE Prevention Plans state that you will remove wild bird nests at (b)(4), your SE monitoring records for both farms indicate that wild bird nests were only removed from houses three times between July 18, 2012 and January 7, 2013. We also note that you had been made aware of this violation previously. During our previous inspection of your facility that occurred on June 14-16, 2011, you were cited for the same violation.
3. You failed to have and implement a written SE Prevention Plan that includes an appropriate monitoring method for rodents and flies, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2). In addition, you failed to maintain records documenting your rodent and fly monitoring activities, as required by 21 CFR 118.10(a)(3)(ii). Specifically, your firm’s SE Prevention Plans for your Panama Ranch and Cottonwood Ranch egg laying farms indicate that fly speck cards and rodent traps will be used to establish a baseline for acceptable levels; however, your SE Prevention Plans fail to define what level of fly and rodent activity is acceptable. In addition, although your SE Prevention Plans require rodent and fly monitoring at least monthly, you were missing fly and rodent monitoring records at each farm location for months prior to July 2012. Further, no rodent traps were observed in any of your poultry houses at the Cottonwood Ranch location. We note if you do not monitor for rodents and flies, you cannot make a determination of whether rodent or fly activity is unacceptable, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2).
We reviewed your response to the FDA 483 received on February 7, 2013. You stated you have re-implemented your fly and rodent monitoring and amended your SE Prevention Plans to state that you need to monitor on at least a weekly basis. The updated SE Prevention Plan attached in your response indicates the new frequency of monitoring; however, you did not provide any supporting documentation demonstrating you implemented the new monitoring frequency. We will evaluate your implementation of your corrective action during our next inspection of your farms. Additionally, your updated SE Prevention Plan fails to establish corrective action threshold for both flies and rodents. Using the number of flies or rodents caught to establish a “baseline” does not allow you to make a determination of whether rodent activity is unacceptable, as required by 21 CFR 118.4(c)(1) and 21 CFR 118.4(c)(2).
4. You failed to hold and transport eggs from both farms at or below 45 degress F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). Specifically, during our inspection at Panama Ranch you stated that you routinely hold eggs that are collected at 5 pm Friday unrefrigerated in your egg processing storage facility until being further processed and packaged Monday morning at 5 am. Therefore, the eggs that you collected at 5 pm on Friday are routinely held at unrefrigerated temperatures for approximately 60 hours.
We reviewed your response to the FDA 483 received on February 7, 2013. You submitted an amended SE Prevention Plan that “Friday’s run will be kept at 45 degrees F or below.” We will evaluate the adequacy of your corrective action during our next inspection of your farms.
5. You failed to maintain records for eggs from both farms documenting compliance with refrigeration requirements, as required by 21 CFR 118.10(a)(3)(iv). Specifically, during the inspection at Panama Ranch our investigator requested your refrigeration monitoring records; however, you were only able to provide records from December 4, 2012 to January 8, 2013. There were no refrigeration records available for any flock from either farm for the timeframe prior to December 4, 2012 because you stated you discarded these records. As required by 21 CFR 118.10(c), all records pertaining to a flock must be maintained for at least one year after the flock is permanently taken out of production.
We reviewed your response to the FDA 483 received on February 7, 2013. You stated you will retain your refrigeration records for at least one year or more. We will evaluate the adequacy of your corrective action during our next inspection of your farm.
The above violations are not meant 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 FFD&C Act, the PHS Act, and the shell egg regulation. You also have the responsibility to use procedures to prevent future violations of these statutes and regulations.
In addition to the above violations, we also have the following comments:
- Please note that you must conduct testing to detect SE in environmental samples using 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, as required by 21 CFR 118.8(a). The environmental sampling and detection method referenced in 21 CFR 118.8(a) requires that each environmental swab sample be placed in a separate whirlpak-type bag and, upon receipt at the laboratory, samples should be stored in a refrigerator for no more than two days. The environmental sampling plan referenced in your SE Prevention Plan indicates that you will pool (b)(4) sample swabs in (b)(4) whirlpak-type bag. If you intend to continue using a sampling protocol other than that which is described in the method entitled “Environmental Sampling and Detection of Salmonella in Poultry Houses,” we encourage you to submit additional documentation to FDA, so that we can determine if your testing methodology, in light of your sampling protocol, is equivalent in accuracy, precision, and sensitivity in detecting SE.
- Your SE Prevention Plans make no reference to many of the records that are required to be kept under 21 CFR 118.10. Please be aware that records are a critical component of any SE Prevention Plan and there are very specific requirements in 21 CFR 118.10(a)(3) regarding maintenance of records documenting compliance with the SE prevention measures. Additionally, your SE Prevention Plans do not indicate how long your firm’s records are kept. Please see 21 CFR 118.10(c) for the specific requirements regarding how long records must be maintained. Lastly, the required records must be available within 24 hours of request for official FDA review as provided in 21 CFR 118.10(d).
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.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved, such as an updated SE Prevention Plan. If you cannot complete all corrections within 15 working days, state the reason for your delay and the time within which the remaining corrections will be completed.
Your written response should be directed to Lawton Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Elizabeth A. Kage
San Francisco District
U.S. Food and Drug Administration