WARNING LETTER
Gravel Ridge Farms
MARCS-CMS 566836 —
February 12, 2019
Product:
Food & Beverages
Egg/Egg Product
Recipient:
Recipient Name
Dustin P. Smith and Daniel B. Wright
Recipient Title
Co-Owners
Gravel Ridge Farms
1550 County Road 1490
Cullman
,
AL
35058-1522
United States
Issuing Office:
Cincinnati District Office
United States
February 12, 2019
WARNING LETTER 566836
UNITED PARCEL SERVICE
Delivery Signature Requested
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:
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)
dozen 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
Content current as of:
02/26/2019
Regulated Product(s)
Food & Beverages
Egg/Egg Product