Inspections, Compliance, Enforcement, and Criminal Investigations
Centrum Valley Farms, LLP (South Complex) 8/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Kansas City District|
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100
August 14, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012 – 13
Jim Dean, CEO and Co-Owner
Cornelius S. Boomsma, COO and Co-Owner
Centrum Valley Farms, LLP
2674 Hwy 69
Clarion, IA 50525
Dear Messrs. Dean and Boomsma:
The United States Food and Drug Administration (FDA) inspected your shell egg production facility located at 2678 270th Street, Clarion, Iowa on April 30 through May 4, 2012. During the inspection, FDA 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 www.fda.gov.
Your significant violations were 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. Specifically, during our inspection your SE prevention plan consisting of the documents titled, “Centrum Valley Farms Bio-Security Plan South Complex” and “Centrum Valley Farms South Salmonella Enteritidis Prevention Plan” failed to include the following required SE prevention measures:
• The section of your SE prevention plan titled “Procedures to Reduce the Threat of SE Contamination” does not include testing of the pullet environment when pullets are 14 to 16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). The procedure listed in your SE prevention plan of testing pullets for the serology of the SE vaccine is inadequate. Serological testing of the pullets does not constitute sampling the environment.
• The section of your SE prevention plan titled “Cleaning and Disinfecting Production Facilities” does not include procedures for removing dust, feathers and old feed from a pullet house for which an environmental test was positive, as required by 21 CFR 118.4(a)(3)(ii).
This section of your SE prevention plan also does not include procedures for disinfecting the positive pullet house, as required by 21 CFR 118.4(a)(3)(iii).
Your revised SE prevention plan received on June 18, 2012, states that environmental testing of the pullet environment will be conducted when pullets are 14-16 weeks of age in accordance with 21 CFR 118.4(a)(2). We will verify this correction during our next establishment inspection.
2. 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). You also failed to conduct environmental testing for SE in the poultry house when laying hens reached 40 to 45 weeks of age as required by 21 CFR 118.5(a). Specifically, records reviewed by our investigators show that between May and September 2011, there were 14 occurrences where the pullet environmental testing was conducted outside of the 14-16 week pullet age time frame. In these instances it was noted that the pullet environmental samples were collected from 10 days early to 16 days after the time frame established in 21 CFR 118.4(a)(2)(i). In reviewing the poultry house environmental sampling records our investigators observed that during November and December 2011 there were 8 occurrences where the samples were conducted from 1 to 19 days before the laying hens reached 40-45 weeks of age.
Your letter dated May 25, 2012, describes how your firm discovered similar deficiencies during an internal audit conducted in (b)(4). The letter also contains a description of your firm’s proposed corrections, which include basing the timing of pullet and laying hen environmental sampling on the hatch dates in the National Poultry Improvement Plan documentation as opposed to basing the sampling on an average age of the pullets and laying hens. FDA anticipates that your proposed corrective actions will increase the likelihood that your firm will collect environmental samples of the pullet environment and poultry house environment during the required time frames. We will verify your compliance with these requirements of the shell egg regulation during our next inspection.
3. You failed to fully implement your written SE prevention plan as required in 21 CFR 118.4. The section of your SE prevention plan titled “Environmental and Egg Sampling – Environmental Sampling” explains that to get a representative environmental sample you will provide twelve (12) individual samples per egg laying house. However, our investigators noted that on at least 18 occasions the third party technician only collected (b)(4) samples per laying house.
Your letter dated May 25, 2012, states that you will retrain the third party technician, conduct random audits of their work, and maintain better documentation. During our next inspection, we will verify that you are conducting your environmental sampling in a manner that is consistent with your SE prevention plan.
4. You failed to maintain records documenting compliance with refrigeration requirements as required in 21 CFR 118.10(a)(3)(iv). Specifically, with respect to your storage of eggs in the cooler, between August 1-31, 2011; September 8-11 and 14-30, 2011; and November 5-11, 2011, you did not maintain records documenting compliance with 21 CFR 118.4(e), which requires that you hold and transport eggs at or below 45°F ambient temperature beginning 36 hours after time of lay. The section of your firm’s SE prevention plan titled “Plant Side Prevention and Care – Refrigeration” states that eggs are to be immediately moved to a cooler and held at 45°F after processing and packing and that complete refrigeration records will be kept and maintained for all eggs.
Your letter dated May 25, 2012, states that your QC Department began documenting the cooler temperatures (b)(4) starting (b)(4). The additional information received on June 18, 2012, contains a copy of your Cooler Temperature Log. We will verify the consistent documentation of the cooler temperatures during our next inspection.
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 a responsibility to use procedures to prevent further violations of these statutes and regulations.
In addition to the above violations, we also have the following comment:
• We are concerned about the presence of Salmonella Heidelberg (SH) in your poultry house environment. During the investigation of the 2010 nationwide SE outbreak where an estimated 2,000 people contracted SE, SH was also found on farms which you now operate. SH is an organism that can transmit via the transovarian route, in a fashion similar to SE. There is a strong body of scientific evidence indicating the primary risk factor for SH illness is shell eggs. Furthermore, SH has caused several egg associated outbreaks resulting in human illness and at times death. Given this body of evidence, FDA considers SH within a poultry house environment to be a public health threat. During the recent investigation, SH was identified in two of the six houses we sampled at the South site. We acknowledge that you have been working with FDA to address this situation.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do 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 time within which the remaining corrections will be completed.
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).
Your written response should be sent to the Food and Drug Administration, Attention: Danial S. Hutchison, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Mr. Hutchison at the number listed in this letter’s header.
John W. Thorsky
Kansas City District
Cc: Steve Moline, Bureau Chief
Wallace State Office Building
502 E. 9th Street
Des Moines, IA 50319