Inspections, Compliance, Enforcement, and Criminal Investigations
Swiss Mountain View Egg Farm 2/3/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
February 3, 2014
WL # 13-14
Charles A. Steiner, Owner
Swiss Mountain View Egg Farm
249 Steffy Road
Ramona, CA 92065 US
Dear Mr. Steiner:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 249 Steffy Road, Ramona, CA 92065 on August 14-16, 2013. We found significant 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 requirements 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 can find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov .
We acknowledge that you stated to our investigators that you intend to reduce the number of laying hens at your farm to fewer than 3,000 so that you are not covered by the requirements of the shell egg regulation. We will verify this action at our next inspection.
Your significant violations are as follows:
1. You failed to have a written SE prevention plan that includes, at a minimum, the SE prevention measures required by 21 CFR 118.4. A written SE prevention plan must include the following SE prevention measures: pullet requirements; biosecurity measures; rodent, fly, and other pest control measures; cleaning and disinfection procedures; and refrigeration procedures. A written plan is necessary for producers to ensure that they have effectively and consistently implemented SE prevention measures.
2. 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, your firm does not conduct any environmental testing for SE at your egg farm. Environmental monitoring for SE, at various timeframes during the life of the flock, is a method of determining the effectiveness of your SE prevention plan and SE prevention measures. In the absence of such testing, there is no way to know the SE status of your poultry houses.
3. You have not registered your egg farm with the FDA by the applicable compliance date of the shell egg regulation, as required by 21 CFR 118.11(a). Specifically, your farm is not currently registered as an egg farm with FDA. The compliance date for shell egg producers with at least 3,000 laying hens, but fewer than 50,000 laying hens, was July 9, 2012. Since your farm has 3,000 or more laying hens and produces shell eggs for the table market, you must comply with the shell egg regulation.
4. You failed to prevent wild birds and cats from entering poultry houses, as required by 21 CFR 118.4(b)(4). Specifically, during the inspection our investigators observed a black cat in poultry house 3 and a dead wild bird inside poultry house 6. Our investigators also observed several wild birds flying out of poultry houses 5 and 6. Additionally, several potential areas of ingress were noted during the inspection such as holes in the wire meshing around the houses and open doorways.
5. You failed to remove vegetation and debris outside poultry houses that may provide harborage for pests, as required by 21 CFR 118.4(c)(3). Specifically, during the inspection our investigators observed excess vegetation and debris around poultry houses that could be potential harborage areas.
This letter is not intended to be an all-inclusive list of your firm’s violations. 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 future 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 the FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR 118.12(a).
Please notify this office, in writing, within fifteen (15) working days from your 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. If you cannot complete all corrections within 15 working days, state the reason for the delay and the time frame within which the remaining corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention:
Blake Bevill, Director
Los Angeles District
Irvine, CA, 92612-2506
Include the FDA Establishment Identifier #3010336687 in all correspondence. If you have questions regarding any issues in this letter, please contact Mr. Robert McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse, Director
Los Angeles District
Charles A. Steiner
PO Box 100
Ramona, CA 92065
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence
California Dept of Food and Agriculture
Animal Health Branch
Attn: Tony Herrera
1220 N Street
Sacramento, CA 95814