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U.S. Department of Health and Human Services

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Enforcement Actions

SKS Enterprises, Inc., dba Honen Ranch 1-4 12/21/12

  

Department of Health and Human Services logoDepartment 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 

 

WARNING LETTER
 
VIA UPS
Signature Required

December 21, 2012
 
Mr. Wen Chang Su, President
SKS Enterprises, Inc.
23709 E. Brandt Road
Lodi, California 95240
 
Dear Mr. Su:
 
The U.S. Food and Drug Administration (FDA) inspected your shell egg production facilities located at:
 
  • Honen Ranch, 23709 Brandt Rd., Lodi, Ca., on May 22-29, 2012 (Inspection 1);
  • Fosberg & Griffin, 4506 Griffin Rd., Hughson, Ca. on June 11-14, 2012 (Inspection 2);
  • Castle, 11818 East French Camp Rd., Manteca, Ca. on June 18-22, 2012 (Inspection 3);
  • Palm View, 13643 Jacktone Rd., Manteca, Ca. on July 23-27, 2012 (Inspection 4);
  • D & C, 5201 Griffin Rd, Hughson, Ca. on August 6-14, 2012 (Inspection 5).
 
We found that the above-listed 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). 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. Our investigators’ observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspections. You may find the FD&C Act, the PHS Act, and the shell egg regulation through links on FDA’s home page at www.fda.gov
 
Your significant violations, with references to each specific farm, are as follows:
 
1.    You failed to conduct environmental testing for SE in the pullet environment when the pullets were 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i).   Specifically, during Inspection 5 at D&C Ranch our investigators reviewed records indicating the pullets in (b)(4)(flock #774810) underwent environmental sampling at (b)(4) of age. 
 
Additionally, your (b)(4) contains conflicting information relating to the pullet age when environmental testing for SE is to be conducted.  Specifically, Appendix VI: Protocol for handling chicks positive for SE, indicates that your pre-production pullet monitoring can occur between (b)(4) of age or before moving the pullets into the laying facility. As described above this timeframe is inconsistent with 21 CFR 118.4(a)(2)(i), which requires that you test the pullet environment when pullets are 14 to 16 weeks of age.  However, (b)(4), indicates that the pullet monitoring test will be conducted when pullets are (b)(4) of age.  
 
You told our investigators that you would implement corrections so that the pullet environment would be tested at the required times. However, you did not submit a written response to the FDA-483 issued for the inspection at D&C Ranch or provide any supporting documentation of your corrective action. We will evaluate the adequacy of your corrective action during our next inspection of your facility. 
 
2.    You failed to fully implement your written SE prevention plan as required by 21 CFR 118.4. Specifically, your SE prevention plan, in use at all five locations, states in Appendix B that “(b)(4).”  However, during Inspection 3 at Castle Ranch our investigators observed a visitor drive a car onto the ranch through the west entrance without washing or disinfecting their vehicle. 
 
3.    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 wild birds in the poultry houses at the following locations:
 
  • During Inspection 2 at Fosberg & Griffin Ranch our investigators observed several wild birds inside Fosberg (b)(4) and Griffin (b)(4). A wild bird nest was observed in the eave of the roof in the southwest corner of Fosberg (b)(4). In addition, all of the poultry houses at Fosberg & Griffin Ranch had a gap along the apex of the roof approximately 6 inches wide. This gap extended the entire length of the poultry houses.
 
We have reviewed your response to the FDA-483 issued after Inspection 2 at Fosberg & Griffin Ranch.  You stated that in the next several months chicken wire will be placed along the apex of the roofs in an effort to keep out wild birds and that you would submit a report to FDA when this correction is completed. We have not received this report. In addition, you stated that the existing wild bird nests would be removed immediately. We will evaluate the adequacy of your corrective actions during our next inspection of your facility. 
 
  • During Inspection 3 at Castle Ranch our investigators observed approximately 15 wild birds in house #2. In addition, (b)(4) at Castle Ranch were observed to have numerous gaps in the walls, ranging from a few inches to a few feet in length.
  • During Inspection 4 at Palm View Ranch our investigators observed approximately 20 wild birds in (b)(4) and several wild birds in (b)(4). In addition, several wild bird nests were observed in houses #5 and #6. Wild birds were observed accessing all (b)(4) houses through the four feet wide gaps in the roofs as well as through several smaller gaps along the walls. 
 
Additionally, your SE prevention plans at Fosberg & Griffin, Castle, Palm View and D&C Ranches, failed to include measures to prevent stray poultry, wild birds, cats, and other animals from entering poultry houses. Your SE prevention plan at Honen Ranch failed to include measures to prevent stray poultry, cats, and other animals from entering poultry houses; the Honen Ranch plan only addresses wild birds. 
 
We have reviewed your responses to the FDA-483s issued after Inspection 1 at Honen Ranch and Inspection 2 at Fosberg & Griffin Ranch.  In both responses, you stated that Section C in your Pest Control Protocol was amended to address both “wild animals and birds.” We note that 21 CFR 118.4(b)(2) requires you to include measures in your SE prevention plans to prevent stray poultry, cats, and another animals from entering poultry houses, and not just “wild” animals and birds. In addition, you failed to include a revised SE prevention plan with your responses. Our investigators also did not observe this change in the Pest Control Protocols of your SE prevention plans during Inspection 3 at Castle Ranch, Inspection 4 at Palm View Ranch, or Inspection 5 at D&C Ranch.  
 
4.    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, during Inspection 3 at Castle Ranch our investigators reviewed records indicating that you failed to environmentally test (b)(4) four to six weeks after the end of the molting process.  Instead you sampled (b)(4) after the end of the molting process. Similarly, during Inspection 4 at Palm View Ranch our investigators reviewed records indicating that you environmentally sampled (b)(4) after the end of the molting process for Flock 773710 in (b)(4), Flock 773711 in (b)(4), and Flock 773712 in (b)(4).
 
5.    You failed to maintain records documenting rodent and other pest control measures, as required by 21 CFR 118.10(a)(3)(ii). Specifically, you failed to consistently maintain fly and/or rodent monitoring records during our inspections at the following locations:
 
  • During Inspection 1 at Honen Ranch  you were missing fly monitoring records for the months of February and March 2012.
  • During Inspection 2 at Fosberg & Griffin Ranch you were missing rodent and fly monitoring records for March 2012.
  • During Inspection 3 at Castle Ranch you were missing rodent and fly monitoring records for February and March 2012.
  • During Inspection 4 at Palm View Ranch you were missing rodent and fly monitoring records for February and March 2012.
  • During Inspection 5 at D&C Ranch you were missing rodent monitoring records for March 2012 and fly monitoring records for February and March 2012.
 
During each of our inspections, you stated that these records were missing because the responsible (b)(4). We have reviewed your response to the FDA-483s issued after Inspection 1 at Honen Ranch and Inspection 2 at Fosberg & Griffin Ranch.  You stated that you had (b)(4) to (b)(4) responsible for monitoring and documenting rodent and pest control protocols. We will evaluate the adequacy of your corrective actions during our next inspection of your facility.
 
7.    Your environmental sampling plan is not appropriate to your poultry house layout, as required by 21 CFR 118.7(a). Specifically, your sampling plan described in (b)(4) of your SE prevention plan for all locations states “(b)(4)” for all (b)(4) systems. Your poultry houses at Fosberg & Griffin, Castle, Palm View, and D&C Ranch are (b)(4) systems. Because you use one swab to monitor two cage rows, your sampling plan samples only half of the cage rows in your (b)(4)poultry houses. This method does not sample all areas of your (b)(4) poultry houses and therefore is not appropriate to your poultry house layout. In FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation,” we recommend that individual drag swabs be used to sample the left and right banks of each manure row in a (b)(4) poultry house, for a total of two samples per row. Our guidance is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm285101.htm.  
 
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 FD&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.
 
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 above violations, we also have the following comment:
 
  • You are required under 21 CFR 118.8(a) to conduct testing to detect SE in environmental samples 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 environmental sampling and detection method referenced in 21 CFR 118.8(a) indicates 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.  However, during all five inspections, your sampling method entailed pooling four swabs per whirlpak-type bag.  In addition, during Inspection 5 at D&C Ranch our investigators reviewed multiple laboratory documents which indicated environmental swab samples were stored for more than 2 days prior to being analyzed.  We have reviewed your response to the FDA-483 issued after Inspection 2 at the Fosberg & Griffin Ranch.  We acknowledge that you provided a citation to a study that compared single versus pooled swabs.  However, your submission failed to include sufficient scientific data for FDA to determine if your method is equivalent to the method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses."  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.
 
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, including an updated SE Prevention Plan. 
 
Your written response to this letter should be sent 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.
 
Sincerely,
/S/ 
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration