Our handling and cooking of eggs has become dependent on egg farmers controlling Salmonella in their flocks. We generally eat eggs with minimal cooking (over easy, poached, or we go Rocky), but there is a risk. For facilities with good controls in place, the Salmonella risk is minimal, but for those farms that don't have good controls, Salmonella can be present in the eggs.
Gravel Ridge Farms, Alabama - Because of a Salmonella outbreak associated with eggs in September, FDA conducted an inspection of egg facility in Alabama. The issues were:
- There was not control program for Salmonella Enteritidis (SE).
- Inadequate cleaning to prevent cross contamination.
- There were no biosecurity measures in place
- There was no pest control program
- They did not clean the facility to remove pest harborage sites.
In the Notice it was noted that the facility was shut down by owners with no plans on reopening.
FDA issued a warning letter to Pitcher Road Farm of Ovid, NY, 14521 after an inspection that took place from August 1 through August 2, 2018. The farm had failed to implement thier SE plan including not testing the environment for SE or implementing measures for preventing cross contamination.
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
February 12, 2019
WARNING LETTER 566836
During the inspection, two environmental samples were collected and analyzed for SE. SE was detected in Sample 1050366, collected from House No. 4; and Sample 1081755, collected from House No. 2, at your farm. FDA acknowledges your voluntary action, on or about September 14, 2018, which included the termination of the entire flock of approximately (b)(4) layer hens held in Houses No. 4 and No. 2 and subsequent disposal/destruction of (b)(4) eggs from the flocks, as witnessed by a representative of the Alabama Department of Agriculture.
FDA investigators’ observations were noted on the Form FDA 483 (FDA 483), Inspectional Observations, listing deviations found during our inspection, which was issued to your farm on September 25, 2018. You submitted a written response which was received on October 8, 2018. We are aware you have currently recalled all eggs, depopulated all flocks, and have ceased egg production. Your response states you are unlikely to become operational. However, if you do, you state you will work with the Alabama Department of Agriculture to ensure you follow the requirements of the egg safety rule. If you plan to resume operations, you should provide documentation of any corrective actions taken including sanitation steps performed in the laying houses. We will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.
Your significant violations were as follows:
1. You did not have and implement a written Salmonella Enteritidis (SE) prevention plan, as required by 21 CFR 118.4. Specifically, prior to the start of the FDA inspection on September 5, 2018, your firm did not have an SE prevention plan in place. However, you submitted a draft written SE prevention plan during the inspection. That plan collected during the inspection is not signed by a designated SE plan administrator. In addition, there is no information specific to the operations or procedures of your farm included in the plan. Additionally, the plan does not adequately address all the required SE preventive measures in 21 CFR 118.4. The SE preventive measures must address the following:
•Procurement of pullets that are SE monitored or raised under SE monitored conditions
•Biosecurity
•Rodents, Flies, and Other Pest Control
•Procedures for Cleaning and Disinfecting the poultry house
•Refrigeration requirements
Pullets
Your draft written SE prevention plan collected during the inspection fails to include a requirement that procured pullets are SE monitored or that pullets are raised under SE monitored conditions, as required by 21 CFR 118.4(a), and that the pullet environment will be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). You also failed to maintain records documenting pullets were raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2).
Specifically, your records show that you purchase chicks from (b)(4). However, your draft SE prevention plan does not indicate that you will procure chicks from SE monitored breeder flocks that meet the NPIP’s standards for “U.S. S. Enteritidis Clean” status or equivalent standard, as required by 21 CFR 118.4(a)(1). In addition, your firm could not provide any supporting documents to show that you tested the pullet environment for SE when the pullets were 14 to 16 weeks of age, as required by 21 CFR 118.10(a)(2)(i). Further, your draft SE prevention plan collected during the inspection does not indicate you will test the pullet environment for SE at 14 to 16 weeks of age.
Biosecurity
You did not have written measures to limit visitors on the farm and in poultry houses; maintain personnel and equipment practices that will protect against cross contamination when people or equipment move between houses; prevent stray poultry, wild birds, cats and other animals from entering poultry houses; and prohibit employees from keeping birds at home to ensure that there is no introduction or transfer of SE onto the farm or among houses, as required by 21 CFR 118.4(b).
Our investigators observed that visitors are not limited on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1). Specifically, during the inspection it was noted there were no visible means to limit visitors from entering the farm's property. Additionally, there were no procedures in place to limit visitors on the farm.
You did not maintain practices that would protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2). Specifically, during the inspection, the FDA investigator observed employees gathering eggs in metal baskets and then taking these baskets of eggs to the processing/packing building, where the baskets of eggs were set on the bare concrete floor awaiting transfer to the wash tunnel. During several visits inside the processing/packing room, the investigator did not observe that any baskets were sanitized before taking them back to the poultry houses to gather more eggs.
You did not maintain practices that would protect against cross contamination when people move between poultry houses, as required by 21 CFR 118.4(b)(3). Specifically, during the inspection, the FDA investigator observed on multiple occasions farm employees entering poultry house four and then poultry house two without changing clothing or boots while gathering eggs.
Rodents, Flies, and Other Pest Control
You did not monitor for the presence of rodents by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1). Specifically, you did not have appropriate monitoring of rodents in poultry houses No. 2 and No. 4, you failed to identify a threshold to indicate what is acceptable and unacceptable rodent activity, and you failed to identify any corrective actions to be taken if unacceptable rodent activity were to be established.
You did not monitor the presence of flies by appropriate monitoring methods, as required by 21 CFR 118.4(c)(2). Specifically, during the inspection, there was no visible means to monitor flies in poultry houses No. 2 and No. 4, you failed to identify a threshold to indicate what is acceptable and unacceptable fly activity, and you failed to identify any corrective actions to be taken if unacceptable fly activity were to be established.
You did not eliminate potential harborages for pests in and outside your poultry house by removing debris and vegetation outside the poultry house, as required by 21 CFR 118.4(c)(3). Specifically, our investigator observed over growth of vegetation located between poultry houses No. 3 and No. 4 which could serve as rodent harborage.
2. An environmental test for SE was not conducted for each poultry house as required by 21 CFR 118.7(a). Specifically, your firm failed to complete an environmental test for SE in each poultry house containing laying hens (houses No. 2 and No. 4).
As required by 21 CFR 118.7(a), environmental testing must utilize a sampling plan appropriate to the poultry house layout. In addition, under 21 CFR 118.8(a), testing to detect SE in environmental samples must be conducted 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. In addition, 21 CFR 118.10(a)(3)(v) requires you to maintain records documenting compliance with environmental and egg sampling procedures, when applicable, performed under 21 CFR 118.7.
We acknowledge your draft SE prevention plan collected during the inspection contains a section titled “Environmental and Egg Testing”; however, it is not adequate in that it does not state that all pullets will be tested (environment) for SE at 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Furthermore, environmental testing for SE, using approved methods, was not conducted in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age, as required by 21 CFR 118.5(a).
The above violations are not meant to be an all-inclusive list of deficiencies at your firm. You are responsible for ensuring your shell egg farm 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).
We acknowledge you have been working with FDA, including recalling approximately 660,000 shell eggs produced between May 22– August 29, 2018. We will verify the implementation of your corrective actions, and their adequacy during the next FDA inspection.
Please notify this office in writing, within 15 working days of the receipt of this letter, as to any other steps you have taken to correct the violations noted above and to ensure similar violations do not occur, including documentation, such as records, photographs, receipts, etc. to demonstrate that corrective actions are in process or have been achieved. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. We are aware you are in the process of performing corrective actions, therefore within 15 working days, you should also provide a timeframe within which the remaining corrections will be completed.
Your written response to this letter should be directed to Compliance Officer Kimberly Dutzek, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Ms. Dutzek at (615) 366-7826.
FDA issued a warning letter to Pitcher Road Farm of Ovid, NY, 14521 after an inspection that took place from August 1 through August 2, 2018. The farm had failed to implement thier SE plan including not testing the environment for SE or implementing measures for preventing cross contamination.
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772
February 12, 2019
WARNING LETTER 566836
Dustin P. Smith and Daniel B. Wright, Co- Owners
Gravel Ridge Farms
1550 County Road 1490
Cullman, Alabama 35058-1522
Dear Messrs. Smith and Wright:
Gravel Ridge Farms
1550 County Road 1490
Cullman, Alabama 35058-1522
Dear Messrs. Smith and Wright:
The United States Food and Drug Administration (FDA) inspected your shell egg farm, located at 1550 County Road 1490, Cullman, Alabama, from September 5 – 7, 12, 20, and 25, 2018. The inspection was initiated as part of a Salmonella Enteritidis (SE) multi-state outbreak investigation by FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network. According to CORE and the Centers for Disease Control and Prevention (CDC), 45 people in 12 states were infected with the outbreak strain of SE, which is the same strain found in one environmental swab from your egg laying house No. 2, and one environmental swab from your egg laying house No. 4. Further, FDA’s Whole Genome Sequence (WGS) analysis of these isolates of SE revealed they are genetically identical to 45 clinical isolates from ill patients sequenced to date. Moreover, as you are aware, CDC and FDA have determined, based on the epidemiological, traceback, and laboratory evidence, that shell eggs produced at your Cullman, Alabama location are the likely source of this multi-state SE outbreak.
In addition, during our inspection we found your firm was in violation of FDA’s egg safety rule, i.e. the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, Title 21, Code of Federal Regulations, Part 118 [21 CFR 118]. 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), 42 United States Code (USC) 264(a). In addition, your shell eggs are adulterated within the meaning of Section 402(a)(4) of the FD&C Act, 21 USC 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 egg safety rule through links on FDA’s Internet home page at www.fda.gov.
During the inspection, two environmental samples were collected and analyzed for SE. SE was detected in Sample 1050366, collected from House No. 4; and Sample 1081755, collected from House No. 2, at your farm. FDA acknowledges your voluntary action, on or about September 14, 2018, which included the termination of the entire flock of approximately (b)(4) layer hens held in Houses No. 4 and No. 2 and subsequent disposal/destruction of (b)(4) eggs from the flocks, as witnessed by a representative of the Alabama Department of Agriculture.
FDA investigators’ observations were noted on the Form FDA 483 (FDA 483), Inspectional Observations, listing deviations found during our inspection, which was issued to your farm on September 25, 2018. You submitted a written response which was received on October 8, 2018. We are aware you have currently recalled all eggs, depopulated all flocks, and have ceased egg production. Your response states you are unlikely to become operational. However, if you do, you state you will work with the Alabama Department of Agriculture to ensure you follow the requirements of the egg safety rule. If you plan to resume operations, you should provide documentation of any corrective actions taken including sanitation steps performed in the laying houses. We will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.
Your significant violations were as follows:
1. You did not have and implement a written Salmonella Enteritidis (SE) prevention plan, as required by 21 CFR 118.4. Specifically, prior to the start of the FDA inspection on September 5, 2018, your firm did not have an SE prevention plan in place. However, you submitted a draft written SE prevention plan during the inspection. That plan collected during the inspection is not signed by a designated SE plan administrator. In addition, there is no information specific to the operations or procedures of your farm included in the plan. Additionally, the plan does not adequately address all the required SE preventive measures in 21 CFR 118.4. The SE preventive measures must address the following:
•Procurement of pullets that are SE monitored or raised under SE monitored conditions
•Biosecurity
•Rodents, Flies, and Other Pest Control
•Procedures for Cleaning and Disinfecting the poultry house
•Refrigeration requirements
Pullets
Your draft written SE prevention plan collected during the inspection fails to include a requirement that procured pullets are SE monitored or that pullets are raised under SE monitored conditions, as required by 21 CFR 118.4(a), and that the pullet environment will be tested for SE when pullets are 14-16 weeks of age, as required by 21 CFR 118.4(a)(2)(i). You also failed to maintain records documenting pullets were raised under SE monitored conditions, as required by 21 CFR 118.10(a)(2).
Specifically, your records show that you purchase chicks from (b)(4). However, your draft SE prevention plan does not indicate that you will procure chicks from SE monitored breeder flocks that meet the NPIP’s standards for “U.S. S. Enteritidis Clean” status or equivalent standard, as required by 21 CFR 118.4(a)(1). In addition, your firm could not provide any supporting documents to show that you tested the pullet environment for SE when the pullets were 14 to 16 weeks of age, as required by 21 CFR 118.10(a)(2)(i). Further, your draft SE prevention plan collected during the inspection does not indicate you will test the pullet environment for SE at 14 to 16 weeks of age.
Biosecurity
You did not have written measures to limit visitors on the farm and in poultry houses; maintain personnel and equipment practices that will protect against cross contamination when people or equipment move between houses; prevent stray poultry, wild birds, cats and other animals from entering poultry houses; and prohibit employees from keeping birds at home to ensure that there is no introduction or transfer of SE onto the farm or among houses, as required by 21 CFR 118.4(b).
Our investigators observed that visitors are not limited on the farm and in the poultry houses, as required by 21 CFR 118.4(b)(1). Specifically, during the inspection it was noted there were no visible means to limit visitors from entering the farm's property. Additionally, there were no procedures in place to limit visitors on the farm.
You did not maintain practices that would protect against cross contamination when equipment is moved among poultry houses, as required by 21 CFR 118.4(b)(2). Specifically, during the inspection, the FDA investigator observed employees gathering eggs in metal baskets and then taking these baskets of eggs to the processing/packing building, where the baskets of eggs were set on the bare concrete floor awaiting transfer to the wash tunnel. During several visits inside the processing/packing room, the investigator did not observe that any baskets were sanitized before taking them back to the poultry houses to gather more eggs.
You did not maintain practices that would protect against cross contamination when people move between poultry houses, as required by 21 CFR 118.4(b)(3). Specifically, during the inspection, the FDA investigator observed on multiple occasions farm employees entering poultry house four and then poultry house two without changing clothing or boots while gathering eggs.
Rodents, Flies, and Other Pest Control
You did not monitor for the presence of rodents by appropriate monitoring methods, as required by 21 CFR 118.4(c)(1). Specifically, you did not have appropriate monitoring of rodents in poultry houses No. 2 and No. 4, you failed to identify a threshold to indicate what is acceptable and unacceptable rodent activity, and you failed to identify any corrective actions to be taken if unacceptable rodent activity were to be established.
You did not monitor the presence of flies by appropriate monitoring methods, as required by 21 CFR 118.4(c)(2). Specifically, during the inspection, there was no visible means to monitor flies in poultry houses No. 2 and No. 4, you failed to identify a threshold to indicate what is acceptable and unacceptable fly activity, and you failed to identify any corrective actions to be taken if unacceptable fly activity were to be established.
You did not eliminate potential harborages for pests in and outside your poultry house by removing debris and vegetation outside the poultry house, as required by 21 CFR 118.4(c)(3). Specifically, our investigator observed over growth of vegetation located between poultry houses No. 3 and No. 4 which could serve as rodent harborage.
2. An environmental test for SE was not conducted for each poultry house as required by 21 CFR 118.7(a). Specifically, your firm failed to complete an environmental test for SE in each poultry house containing laying hens (houses No. 2 and No. 4).
As required by 21 CFR 118.7(a), environmental testing must utilize a sampling plan appropriate to the poultry house layout. In addition, under 21 CFR 118.8(a), testing to detect SE in environmental samples must be conducted 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. In addition, 21 CFR 118.10(a)(3)(v) requires you to maintain records documenting compliance with environmental and egg sampling procedures, when applicable, performed under 21 CFR 118.7.
We acknowledge your draft SE prevention plan collected during the inspection contains a section titled “Environmental and Egg Testing”; however, it is not adequate in that it does not state that all pullets will be tested (environment) for SE at 40 to 45 weeks of age, as required by 21 CFR 118.5(a). Furthermore, environmental testing for SE, using approved methods, was not conducted in a poultry house when any group of laying hens constituting the flock was 40 to 45 weeks of age, as required by 21 CFR 118.5(a).
The above violations are not meant to be an all-inclusive list of deficiencies at your firm. You are responsible for ensuring your shell egg farm 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).
We acknowledge you have been working with FDA, including recalling approximately 660,000 shell eggs produced between May 22– August 29, 2018. We will verify the implementation of your corrective actions, and their adequacy during the next FDA inspection.
Please notify this office in writing, within 15 working days of the receipt of this letter, as to any other steps you have taken to correct the violations noted above and to ensure similar violations do not occur, including documentation, such as records, photographs, receipts, etc. to demonstrate that corrective actions are in process or have been achieved. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. We are aware you are in the process of performing corrective actions, therefore within 15 working days, you should also provide a timeframe within which the remaining corrections will be completed.
Your written response to this letter should be directed to Compliance Officer Kimberly Dutzek, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions regarding this letter, please contact Ms. Dutzek at (615) 366-7826.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
_______________________________________________________________________
Office of Human and Animal Food Operations East
Division 1
WARNING LETTER
CMS #564117
2/12/19
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
_______________________________________________________________________
Office of Human and Animal Food Operations East
Division 1
WARNING LETTER
CMS #564117
2/12/19
Mr. Samuel T. Peachey, Owner
Walnut Ridge Farm 1
1657 Pitcher Road
Ovid, NY 14521-9799
Walnut Ridge Farm 1
1657 Pitcher Road
Ovid, NY 14521-9799
Dear Mr. Peachey:
The United States Food and Drug Administration (FDA) inspected your shell egg farm, located at 1657 Pitcher Road, Ovid, NY, 14521 from August 1 through August 2, 2018. During the inspection, the investigators observed that you have 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. Our investigators’ observations were noted on the FDA 483, Inspectional Observations, which was issued to you on August 2, 2018. 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.
We acknowledge receipt of your response dated August 17, 2018 concerning our investigator’s observations issued to you at the close of the inspection. Our evaluation of your response is discussed below.
Your significant violations are as follows:
1. Your firm failed to implement a written, farm-specific Salmonella Enteritidis prevention plan (“SE Plan”) as required by 21 CFR 118.4. Specifically, on August 1, 2018, you provided a written SE Plan that was provided to you by your egg distributor. However, this SE Plan only contains general information that is not specific to the operations or procedures of your farm. For example, this plan states the number of environmental swabs that must be taken based on the size of the poultry house but does not specify the size of your poultry house. The plan does not address practices to prevent cross contamination for the specific equipment used on your farm and the places where that equipment is used and stored. The plan does not provide specific cleaning and disinfecting procedures for your poultry house or specify how the refrigeration requirements actually occur at your farm. Your SE plan does not include a written “No Birds at Home Policy.”
We have reviewed your response, dated August 17, 2018. In your response, you stated that the “SE Plan will be updated to make more Farm specific” and provided part of an updated SE Plan. However, this updated SE Plan is inadequate because the measures are still not specific to your farm and do not describe how your farm complies with all prevention measures required under 21 CFR 118.4, including specific cleaning and disinfecting procedures for your poultry house, specific refrigeration procedures, and a written “No Birds at Home Policy.”
2. Your firm failed to test the pullet environment at 14-16 weeks of age as required by 21 CFR 118.4 (a)(2)(i). Based on date of hatch of the chicks (November 10, 2017), a test of the pullet environment should have been conducted sometime between February 17, 2018 through March 3, 2018. However, you could not provide any documentation to show that the pullet environment was ever tested for SE for your current flock that you received from the pullet grower at 17 weeks of age.
We have reviewed your response, dated August 17, 2018. In your response, you stated that “pullets that are bought for this farm will have SE test done at 14 to 16 weeks of age.” We will evaluate the sufficiency of your testing and documentation during the next inspection.
3. Your firm failed to maintain records documenting compliance with the SE prevention measures as required by 21 CFR 118.10. Specifically, your firm did not maintain records that detail compliance with SE preventive measures to prevent cross contamination from equipment used in more than one poultry house (21 CFR 118.10(a)(3)(i)).
We have reviewed your response, dated August 17, 2018. Your response states that equipment cleaning will be documented. Because you have not provided us with any documentation, we are unable to evaluate the adequacy of your response. We will evaluate the sufficiency of your documentation during the next inspection. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” provides example of records documenting compliance with SE preventative measures. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm. For example, biosecurity records may include cleaning and disinfection logs for equipment shared among poultry houses.
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:
•In your August 17, 2018 response, you stated that “Rodent bait stations will be placed outdoors and monitored every (b)(4).” We note that rodent monitoring is required in the poultry house and in outdoor access areas that are part of the poultry house (as defined by 21 CFR 118.3). For additional information on rodent monitoring for layers with outdoor access, see Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access), July 2013, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm360028.htm. To the extent this regulation applies to your outdoor access areas, we note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity based on rodents caught within a 7-day period. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
Please send your reply to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Michael R. Dominickat 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
The United States Food and Drug Administration (FDA) inspected your shell egg farm, located at 1657 Pitcher Road, Ovid, NY, 14521 from August 1 through August 2, 2018. During the inspection, the investigators observed that you have 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. Our investigators’ observations were noted on the FDA 483, Inspectional Observations, which was issued to you on August 2, 2018. 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.
We acknowledge receipt of your response dated August 17, 2018 concerning our investigator’s observations issued to you at the close of the inspection. Our evaluation of your response is discussed below.
Your significant violations are as follows:
1. Your firm failed to implement a written, farm-specific Salmonella Enteritidis prevention plan (“SE Plan”) as required by 21 CFR 118.4. Specifically, on August 1, 2018, you provided a written SE Plan that was provided to you by your egg distributor. However, this SE Plan only contains general information that is not specific to the operations or procedures of your farm. For example, this plan states the number of environmental swabs that must be taken based on the size of the poultry house but does not specify the size of your poultry house. The plan does not address practices to prevent cross contamination for the specific equipment used on your farm and the places where that equipment is used and stored. The plan does not provide specific cleaning and disinfecting procedures for your poultry house or specify how the refrigeration requirements actually occur at your farm. Your SE plan does not include a written “No Birds at Home Policy.”
We have reviewed your response, dated August 17, 2018. In your response, you stated that the “SE Plan will be updated to make more Farm specific” and provided part of an updated SE Plan. However, this updated SE Plan is inadequate because the measures are still not specific to your farm and do not describe how your farm complies with all prevention measures required under 21 CFR 118.4, including specific cleaning and disinfecting procedures for your poultry house, specific refrigeration procedures, and a written “No Birds at Home Policy.”
2. Your firm failed to test the pullet environment at 14-16 weeks of age as required by 21 CFR 118.4 (a)(2)(i). Based on date of hatch of the chicks (November 10, 2017), a test of the pullet environment should have been conducted sometime between February 17, 2018 through March 3, 2018. However, you could not provide any documentation to show that the pullet environment was ever tested for SE for your current flock that you received from the pullet grower at 17 weeks of age.
We have reviewed your response, dated August 17, 2018. In your response, you stated that “pullets that are bought for this farm will have SE test done at 14 to 16 weeks of age.” We will evaluate the sufficiency of your testing and documentation during the next inspection.
3. Your firm failed to maintain records documenting compliance with the SE prevention measures as required by 21 CFR 118.10. Specifically, your firm did not maintain records that detail compliance with SE preventive measures to prevent cross contamination from equipment used in more than one poultry house (21 CFR 118.10(a)(3)(i)).
We have reviewed your response, dated August 17, 2018. Your response states that equipment cleaning will be documented. Because you have not provided us with any documentation, we are unable to evaluate the adequacy of your response. We will evaluate the sufficiency of your documentation during the next inspection. We note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” provides example of records documenting compliance with SE preventative measures. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm. For example, biosecurity records may include cleaning and disinfection logs for equipment shared among poultry houses.
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:
•In your August 17, 2018 response, you stated that “Rodent bait stations will be placed outdoors and monitored every (b)(4).” We note that rodent monitoring is required in the poultry house and in outdoor access areas that are part of the poultry house (as defined by 21 CFR 118.3). For additional information on rodent monitoring for layers with outdoor access, see Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access), July 2013, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm360028.htm. To the extent this regulation applies to your outdoor access areas, we note that FDA’s December 2011 Guidance for Industry “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” recommends a procedure for obtaining a rodent index of rodent activity based on rodents caught within a 7-day period. See http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm285101.htm.
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.
Please send your reply to the U.S. Food and Drug Administration, Attention: Michael R. Dominick, Compliance Officer, 222 Bloomingdale Road, Suite 406, White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Michael R. Dominickat 914-682-2826 ext. 20 or email at Michael.Dominick@fda.hhs.gov.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
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