Inspections, Compliance, Enforcement, and Criminal Investigations

MS Fruit & Vegetable Co., LLC 8/10/17

 

  

Black HHS-Blue FDA Logo

 

Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
FAX: (513) 679-2772

 
 

 

August 10, 2017
 
Warning Letter 520207
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Lindsey B. Mabry and Lee D. Boone, Co-Owners
MS Fruit & Vegetable Co., LLC
364 Sunset Loop
Grenada, Mississippi 38901-4517
 
Dear Ms. Mabry and Mr. Boone:
 
On February 13-16, and 28, 2017, U.S. Food and Drug Administration (FDA) investigators inspected your produce warehouse and seasonal pecan shelling operation, located at 364 Sunset Loop, Grenada, Mississippi. This inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (cGMP) requirements in Manufacturing, Packing or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act through links on FDA’s Internet home page at www.fda.gov.  We acknowledge your letter dated February 28, 2017, which was received by the Division on March 14, 2017, in response to the FDA 483, Inspectional Observations. Your response was not adequate, as further described in this letter.
 
1.    You failed to take precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically,
 
a.  Pecan dust, whole pecans, and fragments of pecan nuts and shells were observed on floors, walls, and equipment surrounding the Pecan Sheller.  Your firm shells pecans in an open area; which is in close proximity to where ready-to-eat (RTE) produce is exposed, transported, and stored. 
 
b.  Your (b)(4) pallet jack, had pecan shell dust, fragments of pecan nuts, and fragments of pecan shells on both lifting forks and the pallets jack’s exterior frame. During the inspection, the pallet jack was used to transport pallets of RTE produce throughout the facility and into the walk-in cooler. 
 
c.  Pecan dust residue and fragments of pecan nuts and shells were observed on a wooden table used for repackaging RTE produce.  On February 13, 2017, fragments of pecan nuts were sitting on top of this wooden table along with one case of exposed green bell peppers, one case of exposed cucumbers, and two plastic crates of onions.
 
We acknowledge your February 28, 2017, response to the FDA 483 which states you have relocated the Pecan Sheller to an area where no other products will have contact with pecans or pecan dust whatsoever; however, you did not provide evidence, such as photographs and explanations of the specific location of the Pecan Sheller and how you will prevent any further cross contamination of pecans on ready to eat produce. Furthermore, you did not describe your cleaning process to eliminate the existing apparent pecan residue in your facility. We recommend, your pecan-shelling operation should be physically segregated from non-allergenic food storage and preparation areas to reduce the risk of allergen cross contact.
 
2.    All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash their hands thoroughly and sanitize if necessary to protect against contamination in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time their hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically, on February 16, 2017, an employee was observed using the (b)(4) pallet jack, which was covered in apparent pecan dust, to transport pallets of onions and exposed cabbage into the walk-in cooler. The same employee then handled approximately 400 exposed tomatoes using bare hands contact without washing his hands prior to handling the tomatoes.
 
We acknowledge your February 28, 2017, response to the FDA 483, which states you are putting in a separate handwashing station; however, it does not address training of employees in proper handwashing practices.
 
3.    You failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigators discovered evidence of rodent activity near foods stored in your ready to eat produce warehouse, including:
 
a.  Apparent rodent excreta pellets (aREP) on the floor inside of the walk-in cooler used to store RTE produce.  The aREPs were observed approximately 21 inches from a wooden pallet containing 3/40-pound boxes each of sweet potatoes and on the floor in the southeast interior corner of the cooler approximately eight feet from a wooden pallet containing three 40 lb. boxes each of sweet potatoes.
 
b.  Two dead rodents and two aREPs were observed in an area on top of the walk-in cooler utilized for storage of personal items. One of the rodents was located approximately 15 feet above a potential pest entry point observed in the cooler used to store RTE produce.
 
c.  One apparent decayed rodent tail and too numerous to count apparent rodent hairs, were observed on the south receiving area floor used to receive and load RTE produce.
 
We acknowledge your February 28, 2017, response to the FDA 483, which indicates that you planned to contract with (b)(4) in March to prevent further rodent activity; however, you did not provide evidence that you have started the recommended services or have otherwise eliminated the rodents from your facility.
    
4.    You failed to take proper precautions to protect food from contamination with filth because of deficiencies in plant size and design, as required by 21 CFR 110.20(b)(2).  These conditions limit access for cleaning and inspection for pests. Specifically,
 
a.  An approximately 4 inch by 7 inch potential pest entry point was observed along the bottom of the east interior wall of the walk-in cooler used to store RTE produce.  This potential pest entry point was located approximately two inches from a pallet of exposed RTE celery sticks.  Apparent rodent gnawed peanut shells were scattered on the floor directly in front of the potential pest entry point.
 
b.  Both the west receiving/loading dock door and the sliding door on the north front entrance of the firm were open to the exterior while the doors were not in active use.
 
c.  Two exterior windows on the north wall of the firm were open, each creating a 3 inch by 36 inch opening.
 
d.  An approximately one-inch opening was observed in the brick exterior of the east wall around electrical piping used to supply equipment inside the cooler, which stores RTE produce.
 
We acknowledge your February 28, 2017, response to the FDA 483 and found it to be inadequate for this observation.  Your response states the doors are open while they are loading and unloading produce and are shut after the drivers have left; however, during the inspection, our investigators observed these doors open even when there was no unloading or loading of produce occurring.  Additionally, your response states you are not aware of windows that are open or closed on the exterior part of the building.  Our investigators observed these windows to be open and identified them as potential pest entry points.  It is your responsibility to identify these areas in your facility.  Your response indicates you have sealed the identified area, which appears adequate, but you have not provided evidence, such as photographs of the work completed, to demonstrate that you have corrected the observation.
 
5.    You failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1). Specifically, rusted metal barrels, metal sheeting, and wooden debris were observed to be scattered along the east exterior wall of the facility.
 
We acknowledge your February 28, 2017, response to the FDA 483.  Although you appear to be attempting to correct the violations noted, you have not provided evidence, such as photographs of the work completed, to demonstrate that you have corrected the observation.
 
6.    You failed to used rodenticides under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR 110.35(c). Specifically, rodent stations were open, exposing rodent bait blocks.  Fragments of these rodent bait blocks were directly on the floor in the southeast interior corner of the cooler, approximately eight feet from boxes of exposed sweet potatoes.
 
We acknowledge your February 28, 2017, FDA 483 response, which indicates that you will be replacing damaged rodent traps and will only provide glue or hide out traps in the coolers; however you have not provided evidence that demonstrates you have corrected the observation.
 
7.    You failed to maintain buildings, fixtures and physical facilities in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically,
 
a.  The warehouse roof has an approximately 8 inch by 20 feet opening, which exposes the warehouse to the outside environment.  This opening allowed rainwater to leak into the facility.  This area is also directly above a (b)(4) storage rack used to store peanuts.  On February 15, 2017, the floor directly beneath this area had standing water covering an area approximately 4 feet by 12 feet.
 
b.  The concrete walls inside the walk-in cooler used to store exposed RTE produce had peeling and flaking paint.  During the inspection, exposed RTE tomatoes, green bell peppers, and celery were stored by walls, which were covered in peeling and flaking paint in the walk-in cooler.  The tomatoes and green bell peppers were stored approximately three inches underneath peeling and flaking paint on the west interior wall.  The celery was stored approximately three feet underneath peeling and flaking paint on the east interior wall.
 
c.  The two cooler fan units, located along the east interior wall, of the walk-in cooler used to store exposed RTE produce, were covered with a layer of dust and debris. This dust and debris was located approximately five feet above exposed produce, such as celery, apples, lemons, potatoes, and sweet potatoes.  During the inspection, the cooler fan units were operational and circulating air inside the cooler.
 
d.  An approximately six inch wide steel beam was hanging directly in front of the sliding door leading into the cooler used to store RTE produce.  This steel beam was covered in rust and flaking paint.  Exposed RTE produce was routinely transported through this sliding door approximately 12 feet under the steel beam on February 13-16, 2017.
 
e.  The south end of the firm, used for receiving and loading RTE produce, was covered with spray type insulation.  This insulation appeared to be flaking off the surface of the room. Small pieces of this insulation were on the concrete floor of this receiving/loading area.  The walls of this receiving/loading area are also covered with spray type insulation and unsealed plywood boards.  On February 14, 2017, employees were transporting exposed RTE produce through this area.
 
We acknowledge your February 28, 2017, response to the FDA 483.  Although you appear to be attempting to correct the violations noted, you have not provided evidence, such as photographs of the work completed to demonstrate that you have corrected the observation.
 
8.    Your firm failed to properly maintain plant equipment as to be adequately cleanable and properly maintained, as required by 21 CFR 110.40(a). Specifically, the table used for inspecting and repackaging RTE produce was made of a porous wood material.  Cuts and grooves were observed on this wooden, which is used to visually inspect exposed RTE produce items.
 
We acknowledge your February 28, 2017, response to the FDA 483. Although you appear to be attempting to correct the violations noted, you have not provided evidence, such as photographs of the plastic visqueen material covering the table and how this plastic material is maintained. 
 
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. It is your responsibility to ensure that your products are in compliance with the Act and all applicable laws and regulations, including the Current Good Manufacturing Practice regulation for foods [21 CFR 110] administered by FDA.
 
You should take prompt action to correct these violations cited in this letter.  Failure to do so may result in enforcement regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure and/or injunction.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again.  More specifically, your response should include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed.  Please include copies of any available documentation demonstrating corrections have been made.  Your response should be comprehensive and address all violations included in this Warning Letter.
 
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
 
(b)(3)(A)
 
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring your overall operation and the products you distribute are in compliance with the law.
 
(b)(3)(A)
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
(b)(3)(A)
 
Please send your reply to Kimberly A. Dutzek, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have questions regarding any issues in this letter, please contact Ms. Dutzek via (615) 366-7826.
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

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