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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ohio Fresh Eggs LLC 2/25/11

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775 

February 25, 2011

 
VIA UPS OVERNIGHT
 
WARNING LETTER
CIN-11-160313-05
 
John W. Glessner, CEO
Ohio Fresh Eggs, LLC
10513 Croton Road
Johnstown, OH 43031
 
Dear Mr. Glessner:
 
From November 2 through November 29 and on December 20, 2010, the Food and Drug Administration (FDA) reviewed records of your shell egg production operation. The review was initiated after 13 FDA environmental samples from four of your egg layer sites were confirmed positive for Salmonella Enteritidis (SE). We found that you have serious deviations from the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (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 the Public Health Service Act, (the "PHS Act"), Title 42 U.S.C. Section 264(a). In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.A. 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 Act, the PHS Act, and the shell egg regulation at www.fda.gov.
 
The significant deviations were as follows:
 
1. You failed to divert eggs to a treatment that achieves a 5-log destruction of SE upon receiving notification that any of your four egg tests were positive for SE, as required by 21 CFR 118.6(d). Specifically, your firm’s egg testing at Site (b)(4), House (b)(4) resulted in two consecutive SE-positive egg tests. Your firm became aware of the first SE-positive egg test result on October 4, 2010. However, your firm shipped 798 cases of eggs from House (b)(4), on October 7, 2010 to a table egg processor, rather than an egg treatment facility. After our investigators brought this to your attention, you initiated a recall of the eggs on November 5, 2010.
 
2.   You failed to label the pallet, case, or other shipping container, containing eggs being diverted to treatment, with the statement, "Federal law requires that these eggs must be treated to achieve at least a 5-log destruction of Salmonella Enteritidis or processed as egg products in accordance with the Egg Products Inspection Act, 21 CFR 118.6(f),” as required by 21 CFR 118.6(f). Specifically, you diverted eggs from the following locations without the required labeling:

Site #
House #
Circumstances of Diversion   
 
(b)(4)
(b)(4)
+ SE egg sample  
10/04/2010 – 10/28/2010
(b)(4)
(b)(4)
+ SE environmental sample and no subsequent egg testing under § 118.6(a)                            
10/26/2010 – 11/07/2010
(b)(4)
(b)(4)
+ SE environmental sample and no subsequent egg testing under § 118.6(a)
10/26/2010 – 11/02/2010
(b)(4)
(b)(4)
+ SE environmental sample and no subsequent egg testing under § 118.6(a)
09/22/2010 – 09/28/2010  
(b)(4)
(b)(4)
+ SE environmental sample and no subsequent egg testing under § 118.6(a)
09/22/2010 – 10/04/2010

This letter may not list all of your firm's deviations. You are responsible for ensuring that your firm  operates in compliance with the Act and all regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
 
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237. If you have any questions about this letter please contact Mr. Rabe at 513-679-2700 ext. 163.
 
 
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District