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WARNING LETTER

Rose Acre Farms-Hyde County MARCS-CMS 556924 —


Recipient:
Recipient Name
Marcus (NMI) Rust
Rose Acre Farms-Hyde County

1657 W. Tipton St.

Seymour, IN 47274
United States

Issuing Office:
Atlanta District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Foods –
Division III East
60 Eighth Street N.E.
Atlanta, GA 30309

 

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
 
September 6, 2018
 
Marcus (NMI) Rust, CEO
Rose Acre Farms, Inc.
1657 W. Tipton St.
Seymour, IN 47274
 
Reference: CMS Case # 556924
 
WARNING LETTER
 
Dear Mr. Rust:
 
The United States Food and Drug Administration (FDA) inspected your shell egg farm, including your processing plant, where eggs are cleaned and packaged, located at 1560 Hyde Park Canal, Pantego, NC 27860 from March 26 through April 11, 2018. The inspection was initiated as part of a Salmonella braenderup (S. braenderup) multi-state outbreak investigation. According to the Centers for Disease Control (CDC), 45 people in 10 states were infected with the rare outbreak strain of S. braenderup, which is the same strain found in six environmental swabs from your processing plant and two environmental swabs from your egg laying  house #9. Further, FDA’s Whole Genome Sequence (WGS) analysis of these isolates of S. braenderup revealed that they are genetically identical to 55 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 Pantego, NC location are the likely source of this multi-state S. braenderup outbreak.
 
During the inspection, FDA collected environmental samples from poultry houses and the processing plant. FDA laboratory analyses of the environmental samples collected found the presence of S. braenderup in six (6) environmental swabs in the processing plant in Zones 2 and 3 (Sample #1036614) and two (2) from manure in egg laying house #9 (Sample #1001781). Additionally, Salmonella heidelberg (S. heidelberg) was found in eleven (11) environmental swabs in the processing plant in Zones 2 and 3 (Sample #1036614) and one (1) environmental swab from manure in egg laying house #10 (Sample #1005461).   S. heidelberg has been shown to be able to contaminate eggs via the transovarian route and has been implicated in multiple egg-associated outbreaks. Although S. braenderup and S. heidelberg are not explicitly addressed in the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation rule, Title 21, Code of Federal Regulations, Part 118 [21 CFR 118] (egg safety rule), they are both human pathogens that can cause food to be adulterated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
 
In addition, during our inspection we found that your firm was in violation of FDA’s egg safety rule. 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 U.S.C. § 264(a). In addition, your shell eggs are adulterated within the meaning of section 402(a)(4) of 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 egg safety rule through links on FDA’s home page at www.fda.gov.
 
FDA investigators’ observations were noted on the Form FDA-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection, which was issued to Nathaniel K. Nickolisen, Complex Manager, on April 11, 2018. You submitted a written response on April 30, 2018, a written “restoration plan” on June 28, 2018, and provided an addendum to your “restoration plan” on August 6, 2018. We are aware that you are currently diverting shell eggs from this farm to egg products processing.  Further, you have stated that you are in the process of depopulating all flocks and cleaning and disinfecting all laying houses. Thereafter, you plan to conduct environmental testing of each laying house as verification of your cleaning and disinfecting. In addition, you have contracted and are currently working with a professional rodent extermination company to address the rodent issues at your firm. Furthermore, you committed to improving your good manufacturing practices (GMPs), procedures for cleaning and sanitizing, and environmental monitoring program in the processing plant. We will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.
 
Your significant violations are as follows:
 
1.    You did not take appropriate measures to achieve satisfactory rodent control when monitoring indicated unacceptable rodent activity, as required by 21 CFR 118.4(c)(1). Specifically, a review of your pest control records from September 2017 to March 2018 indicate an ongoing rodent infestation, and the corrective actions taken by your firm have not been effective at reducing the rodent levels within your poultry houses to an acceptable level that is below the threshold established in your SE Prevention Plan.  A review of the pest monitoring forms for the period of September 1, 2017 through March 22, 2018 (29 weeks) revealed the following five houses were consistently operating in a rodent activity range that required corrective actions:
  • Laying house 9 – for 14 weeks, rodent counts were between 11 and 27
  • Laying house 10 – for 26 weeks, rodent counts were between 12 and 22
  • Laying house 11 – for 11 weeks, rodent counts were between 11 and 22
  • Laying house 12 – for 18 weeks, rodent counts were between 11 and 19
  • Laying house 13 – for 20 weeks, rodent counts were between 11 and 18 
Additionally, we note that there were 14 instances when your calculated rodent count was 10.9, and no corrective action was taken. The rodent count table does not measure rodents in tenths but in whole numbers. Therefore, the rodent calculation should be represented as a whole number.  A rodent index of 10.9 should be rounded to 11. 
 
Also, from March 26 through March 28, 2018, the investigators observed more than forty (40) live rodents in eight out of twelve laying houses, specifically:
  • Laying house 10 – Approximately four to five (4-5) live rodents in the pit staging table, several in the pit area, and more than ten (10) rodents in the pit staging area, including baby mice
  • Laying house 13 – Multiple live rodents running around the pit staging area and burrowing in and out of manure piles, and five (5) live rodents in the manure pits
  • Laying house 9 – Three (3) live rodents in manure pit, one (1) live rodent running across the upper level floor, and two (2) dead rodents on the ground.
  • Laying house 11 – One (1) live rodent in manure pit, one (1) live rodent on the bird platform, one (1) dead rodent, and rodent burrows observed in the manure piles and in the large gravel in the front of the laying house
  • Laying house 5 – Three (3) live rodents downstairs, in rows 4 and 5
  • Laying house 8 – Two (2) live rodents downstairs, in rows 1 and 4
  • Laying house 6 – One (1) live rodent, in row 1 pit area
  • Laying house 2 – One (1) live rodent downstairs, in row 4 pit area 
2.    The insanitary conditions and poor employee practices observed in the egg processing plant on March 28, 2018 create an environment that allows for the harborage, proliferation, and spread of filth and pathogens throughout the processing plant that could cause the contamination of egg processing equipment and shell eggs. Specifically,
 
a.  Our investigators observed your employees not following your firm’s sanitation procedure, “Cleaning Procedure for Egg Orientor Belt,” Form #6.7.0 F-3, Version #3, for cleaning of the orientor in the egg processing plant. Employees were observed bypassing the degreaser step and spraying detergent on the equipment, wiping it off, and not allowing it to soak for the prescribed 10-15 minutes.
 
b.  During a review and observation of your cleaning procedures, our investigators observed that you did not perform a sanitizing step following the wash step.
 
During the sanitation walkthrough, firm management stated that (b)(4) is used as a sanitizer with a concentration of (b)(4) ppm or higher on food contact equipment. However, our investigators did not observe this being done until the Sanitation Manager directed an employee to start using the sanitizer. When the employee started using the sanitizer, our investigators observed them not using it properly. Specifically, when our investigator tested the sanitizer with a (b)(4) test strip, the sanitizer was found to have a concentration of 1500 ppm, which is outside of the recommended concentration range of (b)(4) ppm.
 
While cleaning removes food, dirt, and other unwanted visible matter on the surface of the equipment, it does not eliminate pathogenic microorganisms that may be on the equipment surface. Therefore, a sanitizer is necessary to eliminate pathogenic microorganisms on surfaces.
 
c.  Throughout the inspection, the investigators observed condensation dripping from the ceiling, pipes, and down walls onto production equipment, including the crack detector and egg grader, and pooling on floors in foot and forklift traffic pathways.
 
Additionally, we found the following environmental positives in the processing area:

Swab and Salmonella Type
Location
#27--S. braenderup
floor with dried water under a broken egg cart
#69--S. braenderup
pool of standing water from the wash room wall
#71 --S. braenderup
water at a steel door leading to the wash room
#108--S. braenderup
condensate from the ceiling pooling onto the floor to the right of the intake to the wash room
#70--S. braenderup
pallet stored in a pool of water
#71--S. braenderup
water at a steel door leading to the wash room
#109--S. heidelberg
water leaking down a wall from the wash room and pooling onto the floor to the right of the wash room
#120--S. heidelberg
floor with standing water in the middle of the right and left lines

 
d.  The investigators observed multiple maintenance and sanitation employees placing egg buffers (food contact surface) onto the floor, pallets, and on equipment that contained a visible accumulation of grime and food debris, before placing the equipment into service.
 
e.  Throughout the inspection, several production and maintenance employees were observed touching their face, hair, production equipment with an accumulation of grime and food debris, floor, boxes, trash cans, and inedible transport cans, and then touching shell eggs and food contact surfaces such as buffers and rollers without changing gloves or washing hands.   
 
f.  Maintenance employees were observed dragging non-food contact equipment, such as a black electrical conduit with an accumulation of grime and food debris, on top of food contact surfaces (i.e., conveyors and rollers).
 
g.  Throughout the inspection the investigators observed equipment such as conveyor belts, chains, rail guards, buffers, egg transport arms, egg clappers, production computers, and exterior equipment surfaces with an accumulation of dried eggs, shells, and grime post sanitation. These same areas were observed uncleaned on multiple days during the inspection pre and post sanitation.
 
h.  The investigators observed a sanitation employee utilizing a steel wool scrubber to scrub debris off egg buffers in service, post sanitation. The steel wool scrubber was stored on a cart in a dustpan that contained water, liquid egg, and visible floating grime. Furthermore, the dustpan was stored with a green squeegee, which was used across the plant to clean egg debris off the floor.
 
Additionally, environmental swab #28 of a squeegee used to clean up broken eggs in the packing area was found positive for S. braenderup (Sample #1036614).
 
i.  Throughout the inspection, the investigators observed flying insects throughout the egg processing plant; the insects were observed landing on food, food contact surfaces, and food production equipment.
 
The above violations are not meant to be an all-inclusive list of deficiencies at your firm. You are responsible for ensuring that your shell egg production operates in compliance with applicable statutes and regulations, including the FD&C Act, the PHS Act, and the egg safety rule. You also have the responsibility to use procedures to prevent future violations of these statutes and regulations.
 
You should ensure you are taking prompt action to correct the violations cited in this letter. Failure to correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.
 
We acknowledge that you have been working with FDA, including recalling over 206 million shell eggs produced between January 11, 2018 and April 12, 2018, and providing documentation of your corrective actions as described earlier in this letter. We will verify the implementation of your corrective actions, and their adequacy during the next FDA inspection.
 
Please notify this office in writing, within fifteen (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 that 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 that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. We are aware that you are in the process of performing corrective actions, therefore within fifteen (15) working days, you should also provide a timeframe within which the remaining corrections will be completed.
 
Your written response should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. If you have any questions about this letter, please contact Ms. King at (843) 746-2990 Ext. 16 or via email at janice.king@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia-North Carolina-South Carolina)
Office of Regulatory Affairs
 
 
Cc:         
Anita MacMullen, Director
NCDA Food & Drug Protection Div
1001 Mail Service Center
Raleigh, NC 27699-1001
                               
cc:          
Nathaniel Nickolisen, Complex Manager
Rose Acre Hyde County Egg Farm
1560 Hyde Park Canal
Pantego, NC 27860