| Public Health Service Food and Drug Administration |
Minneapolis District Office |
Department of Health and Human Services
August 30, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 11- 51
Gary Forsman
CEO/President
Forsman Farms, Inc.
P.O. Box 699
Cokato, Minnesota 55321
Dear Mr. Forsman:
The Food and Drug Administration (FDA) inspected your shell egg production facility located at 6339 Mowery Avenue SW, Howard Lake, Minnesota, on April 12-15, 2011. During the inspection FDA found that your facility 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 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.
Your significant violations were as follows:
1. Although your rodent monitoring indicated unacceptable rodent activity within your poultry houses, you failed to use appropriate methods to achieve satisfactory rodent control, as required under 21 CFR 118.4(c)(1). Specifically, between the weeks of September 29, 2010, and March 23, 2011, your firm recorded that the sum of trapped rodents found in all of your egg laying houses during the course of each of those weeks was in excess of (b)(4), resulting in a rodent index that exceeded (b)(4) for each of these weeks. However, you failed to use appropriate methods to achieve satisfactory rodent control. Your written response dated April 26, 2011, stated that you have changed your threshold level at which you will take corrective action to (b)(4) from (b)(4). You also stated that you have changed the rodent control section of your written Salmonella enteritidis (SE) prevention plan to state that additional corrective action will only be taken after rodent monitoring finds the rodent index is exceeded for (b)(4) consecutive weeks. FDA finds that your proposed correction to this violation is not adequate. The changes you have made to your SE plan are not appropriate methods to achieve satisfactory rodent control.
2. You failed to procure pullets that are SE monitored or to raise pullets under SE monitored conditions, as required under 21 CFR 118.4(a). SE monitoring includes testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required under 21 CFR 118.4(a)(2)(i). Specifically, our inspector learned from your test records that hens from Barn (b)(4) flock #105004, include pullets from Montevideo, MN, houses 205, 206, 207, which were not tested for SE between 14 to 16 weeks of age. The pullet house testing was completed on July 2, 2010, when the pullets were approximately 12 weeks of age. We acknowledge that your SE plan currently specifies that pullet houses be tested within the correct age range.
3. You failed to hold eggs at or below 45 degrees Fahrenheit ambient temperature beginning 36 hours after time of lay, as required under 21 CFR 118.4(e). Specifically, your Loader Cooler that is used to hold shell eggs intended for the table market was not maintained to provide a temperature at or below 45 degrees Fahrenheit. Temperatures in the Loader Cooler were documented above 45 degrees Fahrenheit at several different points in time, including throughout the time period from April 13 - 10, 2011. Documentation also showed eggs being held in the Loader Cooler during that time period that were more than 36 hours past the time of lay. Your written response dated April 26, 2011, stated that you had ordered a new cooling unit. FDA will verify this correction during the next inspection.
4. You failed to fully implement your written SE prevention plan, as required under 21 CFR 118.4. Specifically:
• You did not take the corrective actions described in your plan when your plan parameters for rodent activity levels were exceeded. The rodent control section of your written SE prevention plan states that corrective action must be taken and recorded when weekly rodent monitoring results in a rodent index exceeding (b)(4). However, on at least five occasions between the weeks of September 29, 2010, and March 23, 2011, you took no corrective action even though your weekly rodent monitoring resulted in a rodent index exceeding (b)(4).
• You did not take the corrective actions described in your plan when your plan parameters for temperature control were exceeded. The refrigeration policy section of your written SE prevention plan states that any time the temperature in your cooler falls above or below the 40-45 degree Fahrenheit range specified in your plan, a corrective action must be taken in order to fix the problem. However, your records indicate that the temperature in your Loader Cooler repeatedly exceeded 45 degrees Fahrenheit in December 2010, March 2011, and April 2011. It was not until April 13, 2011, that your records indicate the planned corrective action of purchasing a backup cooling system.
5. You failed to maintain records documenting compliance with the refrigeration requirements of the shell egg regulation, as required under 21 CFR 118.10(a)(3)(iv). Specifically, you did not maintain documentation of the temperature conditions of your Loader Cooler between July 9, 2010, and September 21, 2010. Your written response dated April 26, 2011, acknowledges that no records were created and implemented for monitoring the cooler temperature until September 2010 and that the cooler temperatures have been recorded daily since September 22, 2010.
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 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 respond in writing within 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).
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at the number listed in this letter's header.
Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
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