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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hohberg Poultry Ranch F1/F2 8/30/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Los Angeles District
Pacific Region
19701 Fairchild
lrvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER

WL # 42-12

VIA UPS OVERNIGHT
SIGNATURE REQUIRED

August 30, 2012

Robert A. Hohberg, Owner
Hohberg Poultry Ranches
13814 S. Grove Avenue
Ontario, California 91761

Dear Mr. Hohberg:

The U.S. Food and Drug Administration (FDA) inspected your shell egg production facilities located at:
 

• 7716 Chino Avenue, Ontario, California 91761 on April 3-6, 2012 (Inspection 1: Ranch #1 farm);
• 16493 Santa Ana Avenue, Fontana, California 92337 on April 24-30, 2012 (Inspection 2: F1/F2 farm); and
• 13814 S. Grove Avenue, Ontario, California 91761 on April 30-May 4, 2012 (Inspection 3: Grove Ranch 5 farm).

We found that the above-listed farms have serious violations of the Prevention of Salmonella Enteritidis (SE) in Shell During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). The failure to adequately implement the requirements in 21 CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the ''PHS Act"), Title 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 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 Act, the PHS Act, and the shell egg regulation through links on FDA's home page at www.fda.gov.

The significant violations, with references to each specific farm, are as follows:

1. Your SE prevention plan for your F1/F2 farm failed to include practices that will protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2), and 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 at your F1/F2 farm that will protect against cross contamination when persons and equipment move between poultry houses, as required by 21 CFR 118.4(b)(3) and 21 CFR 118.4(b)(2). Specifically, during Inspection 2 at the F1/F2 farm, our investigator observed a common corridor in which employees and equipment from each F1 poultry house traveled to reach the egg storage location. During the inspection your firm had not implemented practices for protecting against cross contamination when personnel and equipment move between poultry houses, such as removing any caked debris from boots, footwear, equipment, etc., or implementing the use of adequate foot dips, etc.

We note that during the close-out meeting for Inspection 2, Mr. Timothy Hohberg stated that your firm had placed (b)(4) disinfectant footbaths at each poultry house at the F1/F2 farm. However, your prevention plan for the F1/F2 farm has not been revised to include this measure or to include measures for protecting against cross contamination when equipment is moved between poultry houses at the F1/F2 farm. Additionally, your firm has not addressed what measures you have in place for protecting against cross contamination when equipment is moved between poultry houses at the F1/F2 farm.

2. Your SE prevention plans for all three farms failed to include practices that will protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2). Specifically, during Inspection 1 at the Ranch #1 farm and Inspection 3 at the Grove - Ranch 5 farm, Mr. Timothy Hohberg informed our investigators that your firm uses the same manure scraper equipment at all three of your farms. Because your manure scraper equipment could transmit SE, your SE prevention plans should include practices to ensure that this equipment does not cross contaminate your farms. Additionally, although Mr. Timothy Hohberg informed our investigators that the manure scraper is cleaned and disinfected prior to being transported to a new farm, this practice is not sufficient to protect against cross contamination among poultry houses at the same farm. Your firm should clean and disinfect the manure scraper prior to its use at a poultry house, regardless of whether that poultry house is at a farm with multiple poultry houses or at a different farm. You also failed to provide records documenting any cleaning and disinfection of the manure scraper. Under 21 CFR 118.10(a)(3)(i), you must maintain records documenting compliance with SE prevention measures, including biosecurity measures.

3. Your SE prevention plans for all three farms 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 CPR 118.4(b)(4). Specifically, our investigators observed wild birds, cats, or other animals in the poultry houses at the following locations:
 

a. During Inspection 1 at the Ranch #1 farm, we observed at least one cat on the ground inside the poultry house between rows of caged birds, several small birds on the ground between many rows of caged birds inside the poultry house, and several small birds perched along the supporting beams of the poultry house. 

b. During Inspection 2 at the F1/F2 farm, we observed small birds entering the poultry houses through the roof. 

c. During Inspection 3 at the Grove - Ranch 5 farm, we observed numerous small birds on the East and West walkways along the perimeter of the inside of house (b)(4).
 

We have reviewed your response to the FDA-483 received on April 17, 2012 after Inspection 1 at the Ranch # 1 farm. You stated that "in California, in open sided [poultry] houses, it is not possible to control all wild birds and same animals/pests." We find that this response is inadequate, and that at a minimum there must be measures in place to prevent stray animals from entering your poultry houses as required by 21 CFR 118.4(b)(4). Stray animals may be a source of SE that can be transmitted to your poultry flocks, and you must take measures to prevent this potential contamination from occurring.
 

4. Your SE prevention plans for all three farms failed to include procedures for removal of debris within a poultry house and vegetation and debris outside a poultry house which may provide harborage for pests, and you also failed to remove vegetation and debris outside a poultry house, as required by 21 CFR 118.4(c)(3). Specifically, during Inspection 2 at the F1/F2 farm, our investigator observed a buildup of cluttered debris along an outside wall of the F1 poultry houses including old equipment and cob webbing, and also found vegetation growing in outside areas between F1 poultry houses. In addition, during Inspection 1 at the Ranch # 1 farm, our investigators noted old fencing that was rolled-up and stacked along the outside perimeter of the west side near the poultry house providing a potential harborage area for pests. Our investigators also observed a leaking well water tank on the east side perimeter with pooled water and vegetation growth on the ground. Furthermore, during Inspection 3 at the Grove - Ranch 5 farm, our investigators observed leaking water between some poultry houses, causing extensive pooled water in some areas and vegetation growth. Investigators also observed large amounts of spilled feed on the walkways inside the Grove - Ranch 5 farm, house (b)(4), due to holes in the feeding trough that can serve to attract wild birds into the poultry house. These items were discussed with Mr. Timothy Hohberg during each of the inspections and corrective actions were promised. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.

5. Your SE prevention plans for all three farms lacked cleaning and disinfection procedures for use when an environmental test or an egg test is positive for SE, as required by 21 CFR 118.4(d). Your SE prevention plans list general cleaning procedures (e.g. (b)(4)) that are not specific to the requirements of the shell egg regulation. We note that your response to the FDA-483 received on April 17, 2012 included a supplemental form titled "(b)(4)." Although this form lists some of the procedures required by 21 CFR 118.4(d), the form is inadequate because it does not address manure and feed removal, as required by 21 CFR 118.4(d)(1) and (2). In addition, the form does not include any details on how you will accomplish these cleaning and disinfection procedures in the event of an SE-positive environmental test. Such details are essential to ensure that adequate procedures are followed every time a poultry house requires cleaning and sanitizing.
 

6. Your SE prevention plans for all three farms failed to include procedures for holding and transporting at or below 45°F ambient temperature beginning 36 hours after time of lay, as required by 21 CFR 118.4(e). Additionally, your refrigeration records at the Ranch #1 farm and F1/F2 farm did not include the time at which refrigerator cooler temperatures were recorded. This practice caused you to violate 21 CFR 118.10(b)(2), which requires you to include the date and time of the activities reflected in your records.

We have reviewed your response to the FDA-483 received on April 17, 2012 after Inspection 1 at the Ranch #1 farm. You stated that the time eggs enter and leave the cooler will be recorded and attached a revised form for recording these times. Mr. Timothy Hohberg also informed our investigators that you will record the times at which refrigerator cooler temperatures are checked. However, your response is inadequate because you failed to provide any supporting documentation that you are using the revised form to record these times. You also failed to provide any supporting documentation that you revised your SE prevention plans to include these procedures. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.

7. 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:
 

a. During Inspection 1 at the Ranch #1 farm, our investigators observed a flock of laying hens that was 77 weeks of age at the time of the inspection. No SE environmental testing had been performed on this poultry house.
 

b. During Inspection 2 at the F1/F2 farm, you were unable to provide records of any SE environmental testing for poultry houses (b)(4). In addition, testing records for poultry houses (b)(4) and (b)(4) show that SE environmental testing was performed when the laying hens were 55 weeks of age.
 

c. During Inspection 3 at the Grove - Ranch 5 farm, our investigators noted that no environmental testing had been conducted in poultry house (b)(4) where laying hens were 75 weeks of age at the time of the inspection. No environmental testing had been conducted in poultry house (b)(4) where laying hens were 123 weeks of age at the time of the inspection. Additionally, our investigators reviewed records showing that poultry house (b)(4) was tested when the laying hens were 51 weeks of age.
 

8. 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 the Grove- Ranch 5 farm, our investigators noted that you failed to environmentally test the poultry house (b)(4) four to six weeks after the end of the molting process. These birds were molted at 82 weeks of age, and were 90 weeks of age during the inspection.

9. You failed to conduct testing to detect SE in environmental samples using the method titled "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). Specifically, your sampling scheme does not account for sampling of all manure piles with a separate drag swab. We do not consider using a drag swab to sample more than one manure bank to be an equivalent method in accuracy, precision and sensitivity in detecting SE. A different drag swab should be used for each manure bank to avoid saturation of the swab and potential masking of SE by other bacteria. Also, we note that your "SE Swab Flock Monitoring Procedures" document directs your personnel to swab (b)(4) "fertilizer," but the appropriate term is "manure."

10. You failed to implement appropriate rodent monitoring methods, as required by 21 CFR 118.4(c)(1). Specifically, during Inspection 3 at the Grove Ranch 5 farm, a review of your contracted pest control company rodent monitoring records from May 5, 2011 through April 10, 2012 showed that the pest control company was not recording the number live and/or dead rodents. The records document only whether rodent activity was present or not. Relying solely on this metric does not allow you to make a determination of whether rodent activity is unacceptable, as required by 21 CFR 118.4(c)(1). Your SE prevention plans for your F1/F2 farm, and Grove - Ranch 5 farm state that your contract pest control company will take appropriate actions when the rodent index is above ''1." However, it is not possible to calculate the rodent index without first determining the number of live and/or dead rodents.

11. Although you may store records documenting rodent and other pest control measures offsite, you must be able to retrieve and provide the records at your place of business within 24 hours of request for official review, as required by 21 CFR 118.10(d). Specifically, during Inspection 1 at the Ranch #1 farm, our investigators noted that you did not have records from July 9, 2010 to November 28, 2010 to document rodent monitoring and that you did not have records from July 9, 2010 to October 29, 2010 to document fly monitoring. We have reviewed your response to the FDA-483 received on April 17, 2012 after Inspection 1 at the Ranch #1 farm. You stated that your pest control contract company maintains these records off-site and that the company's "contact numbers are included in paper work." It is your responsibility to retrieve and provide these records within 24 hours of the request for official review, as required by 21 CFR 118.10(d).

12. You failed to include in your required records the signature or initials of the person performing the operation or creating the record, as required by 21 CFR 118.10(b)(3). Specifically, during Inspection 2 at the F1/F2 farm, refrigeration temperature monitoring logs did not have the signature or initials of the person performing the operation. In addition, during Inspection 1 at the Ranch # 1 farm, our investigators found that your written SE prevention plan was not signed or dated. Furthermore, during Inspection 3 at the Grove - Ranch 5 farm, we found that your written SE prevention plan was not dated. These items were discussed with you during each of the inspections and corrective actions were promised. We will evaluate the adequacy of any proposed corrective action during our next inspection of your farms.

This letter is not intended to be an all-inclusive list of violations at your farms. You are responsible for ensuring that your shell egg production farms operate in compliance with all applicable statutes and regulations, including the 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.

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 comments:
 

• Pullet procurement records collected during Inspection 1 at the Ranch #1 farm and during Inspection 3 at the Grove - Ranch 5 farm, show that the National Poultry Improvement Plan (NPIP) Form 9-3 for flocks shipped to Ranch #1 (b)(4) and to Grove Ranch 5 on (b)(4) do not have the "S. Enteritidis clean'' box checked off. The remarks section of some of the NPIP Forms 9-3 say "NPIP 42.250 AI-SE tested,'' but no additional documentation was provided to show that the pullets were in fact SE clean, as required by 21 CFR 118.4(a)(1).

• FDA environmental sampling conducted during Inspection 2 at the F1/F2 farm indicated the presence of Salmonella Enteritidis in poultry house (b)(4). We acknowledge that, upon being notified of these findings, you initiated egg testing in accordance with 21 CPR 118.6, the results of which have all been negative.

• FDA environmental sampling conducted during Inspection 3 at the Grove- Ranch 5 farm, indicated the presence of Salmonella Enteritidis in poultry house #1-5B. We acknowledge that, upon being notified of these findings, you initiated diversion of eggs from this house in accordance with 21 CFR 118.6(a)(2).
 

Within 15 working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the above violations and prevent their recurrence. Include an explanation of each step being taken to correct the violations and prevent their recurrence, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 

Please send your written response to this letter to the Food and Drug Administration, Attention:
 

Blake Bevill, Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 

If you have questions regarding any issues in this letter, please contact Robert McNab, Compliance Officer at 949-608-4409.
 

Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District

Cc:
Ingeborg Small, Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
 

Maurice Pitesky DVM, MPVM
California Dept of Food and Agriculture
Animal Health Branch
Attn: Maurice Pitesky
1220 N Street
Sacramento, CA 95814