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WARNING LETTER

Simply Fresh Fruit MARCS-CMS 499090 —


Recipient:
Simply Fresh Fruit


United States

Issuing Office:
Los Angeles District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE                                                           
SIGNATURE REQUIRED
 
 
October 19, 2016                                                                                                                 
WL # 04-17
Mr. William T. Sander, President
Simply Fresh Fruit
4383 Exchange Avenue
Vernon, CA 90058-2619
 
Dear Mr. Sander:
 
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) fresh cut fruit manufacturing facility located at 4383 Exchange Avenue, Vernon, California on April 20, 25-26, 29, and May 2, 4, and 10, 2016. During the inspection, FDA collected environmental samples from various areas in your processing facility.  FDA laboratory analyses of the environmental swabs collected found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. In addition, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).[1]  Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your ready-to-eat fresh cut fruit products are 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 were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
 
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s responses including those dated May 27, 2016, and June 13, 2016, to our environmental findings and to the FDA-483. We will ascertain the adequacy of your corrective actions during our next inspection.
 
Presence of L. monocytogenes 
 
FDA’s laboratory analysis of the environmental samples (INV 855870) collected on April 20, 2016, from your firm’s high care processing room confirmed that three (3) of one hundred (100) environmental swabs were positive for L. monocytogenes. Specifically,
 
-    Two (2) environmental swabs were collected from locations that were in areas adjacent to food contact surfaces. These surface areas include:
o   The panel surface and power switch on side of wash bin located at south end of Line (b)(4)
o   The red power knob for upper blue conveyer belt located at north end of Line (b)(4)
-    One (1) environmental swab was collected at the north end of Line (b)(4) from the blade of a blue squeegee used to push excess water into the drain on the floor
 
Furthermore, finished product from your facility was previously found to be positive for L. monocytogenes. Your firm filed a reportable food report (RFR) and conducted a voluntary recall of a cut cantaloupe lot processed on March 28, 2016, and packed on March 29, 2016, due to a L. monocytogenes positive finding. 
 
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.
 
Whole Genome Sequencing (WGS) analysis was conducted on the three (3) L. monocytogenes isolates obtained from the FDA environmental samples collected on April 20, 2016, and the one (1) RFR L. monocytogenes isolate obtained from the lot of cut cantaloupe processed on March 28, 2016. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. The WGS analysis showed that the four (4) isolates belong to the same strain of L. monocytogenes, suggesting that the three (3) isolates found in the environment of the facility and the single isolate found on finished product originated from the same source of contamination. 
 
The presence of L. monocytogenes in your facility is significant in that it demonstrates that your sanitation efforts are inadequate to effectively control pathogens on your processing equipment and in your facility to prevent contamination of food. Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive, and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
 
We acknowledge your responses revealing continuous findings of L. monocytogenes in your processing environment despite your corrective actions. You have determined your root cause to be “the condition of your dairy tile flooring” and have implemented more aggressive sanitation procedures for your floors and have made corrections to your floors. We will ascertain the adequacy of your corrective actions during our next inspection.
 
cGMP Violations
 
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
 
1.    Your firm failed to handle work-in-process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). Specifically, our investigators observed the following:
 
a)  In the high care processing room, during processing of honeydew melons and cantaloupes, an employee was using a knife with gloved hands to remove the rind and cut the melons. The employee then touched the power switch/knob at the end of the line to turn on the conveyor belt and continued to handle and process the RTE melon chunks without first cleaning and/or sanitizing gloves prior to touching the fruit.
 
b)  Employees were observed on the start of each line touching the handle of a pallet jack to transport bins of pre-washed melons from the low care transfer doorway to the high care processing room, transferring pre-washed melons from the transport bin into the wash bin for sanitizing, then removing the melons from the sanitizing bin containing chlorine and ozonated water, and placing the melons on the blue processing line conveyor belt without cleaning and/or sanitizing gloves prior to performing each step.
 
c)  Plastic lined pails containing washed and RTE grapes were stored on a pallet near the hand washing sink in the low care area. Bins of pre-washed watermelon and papaya were returned to the low care area after being stored in the high care processing room during cleaning and sanitation operations. These bins of pre-washed fruit were also observed being stored near the same hand wash sink in the low care area.
 
d)  Uncovered bins containing pre-washed oranges, honeydew melons, mangos, papayas, and watermelons were observed being stored in the high care processing room during cleaning and sanitation operations.
 
e)  In the low care area, the (b)(4) bin dumper on the scrub brush washer machine was in direct contact with the wet floor. This piece of equipment was also being used to transfer grapefruit and cantaloupe into the chlorinated wash bin for the pre-wash sanitation operation.
 
f)  The (b)(4) bin dumper on the citrus line in the high care processing room was observed in direct contact with the wet floor. The (b)(4) bin dumper was observed dumping grapefruit into chlorinated wash bins.
 
g)  An employee operating a forklift was going through standing water to deliver pallets containing pre-washed fruit such as melon to the high care receiving area. These activities could cause water to backsplash onto equipment and fruit products.  
 
We acknowledge that your response states that you have trained your employees on proper storage of fruit; however, your response did not address training pertaining to prevention of cross contamination. Additionally, your firm’s response states that your low care area and high care area have elevated both the [(b)(4)] bin dumper frames 12” off the floor. However, this alone may not prevent cross contamination from standing water if splashing occurs. We will ascertain the adequacy of your corrective actions during our next inspection.
 
2.    Your firm failed to clean and sanitize food-contact surfaces in wet-processing before use, to preclude contamination with microorganisms as required by 21 CFR Part 110.35(d)(2). Specifically, citrus fruit build-up was observed on the scrub brush washer machine during the pre-washing and sanitation of cantaloupes in the low care area. The areas observed with citrus build-up include the ramp from the wash bin conveyor to the scrub brush rollers.
 
Your firm’s response states that fruit build-up will be removed upon each changeover of fruit and the drain wash bin will be drained and refilled with sanitizer solution. We will ascertain the adequacy of your corrective action during our next inspection.
 
3.    Your firm failed to provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor, as required by 21 CFR Part 110.37(b)(4). Specifically, our investigator observed the following:
 
a.  A large amount of standing water was observed near the drain in the low care area of your processing facility. This standing water was observed near the scrub brush washer machine which is used to pre-wash and sanitize whole fruit including cantaloupes, oranges, and grapefruits. 
b.  An employee was using a squeegee to move water into the drain which was in close proximity to the (b)(4) bin dumper on the scrub brush washer machine.
 
Your response states that you have scheduled to have a drain installed between the existing drains to alleviate the standing water by June 12, 2016. We will ascertain the adequacy of your corrective action during our next inspection.
 
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 Part 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.
 
Section 743 of the Act (21 U.S.C. 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 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, 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.
 
You should respond in writing within fifteen (15) working days of receiving this letter. Your response should outline the specific steps you are taking to correct these violations, 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 your firm has taken. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
 
Your firm’s response should be sent to: 
 
Kelly D. Sheppard, Director
Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
 
If you have any questions about the content of this letter please contact: Rochelle A. Rolnik, Acting Compliance Officer at rochelle.rolnik@fda.hhs.gov (949) 608-4496.
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
                                                                                                                              
Cc:
 
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413


[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.