WARNING LETTER
Kwokcheng Enterprise, Inc. dba Fullei Fresh
MARCS-CMS 579900 —
October 22, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Kwok-Cheng Wong
Recipient Title
President
Kwokcheng Enterprise, Inc. dba Fullei Fresh
400 NE 67th Street
Miami
,
FL
33138-5645
United States
Issuing Office:
Office of Human and Animal Food Operations East Division IV
466 Avenida Fernández Juncos
San Juan
,
PR
00901-3223
United States
WARNING LETTER
20-HAFE4-WL-01 / CMS No. 579900
Dear Mr. Wong:
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation
located at
400 NE 67
th
Street in Miami, FL 33138-5645 from January 28, 2019, through March 11, 2019.  During the inspection, FDA collected environmental samples from various areas in your sprouting operation. FDA laboratory analysis of the environmental swabs identified the presence of
Listeria monocytogenes
(
L. monocytogenes
), a human pathogen, in your sprouting operation.  The inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112).  Based on FDA’s inspectional findings and the analytical results for product samples and environmental samples, we have determined that your products, such as your bean sprouts, 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.  Based on the analytical results for your organic bean sprouts product that yielded
L. monocytogenes
, we have also determined that your organic bean sprouts are adulterated within the meaning of Section 402(a)(1) of the Act [21 U.S.C. § 342(a)(1)] in that your bean sprouts bear or contain any poisonous or deleterious substance which may render it injurious to health.
In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)].You can find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, listing the deviations found at your sprouting operation during our inspection.  We acknowledge receipt of your response received on
March 21, 2019,
to the FDA-483, which included corrective actions you have implemented or plan to implement.  We address your response below.
Pathogen Findings
L. monocytogenes
is a pathogenic bacterium that is widespread in the environment and may be introduced into a sprouting operation from raw materials, humans, or equipment.  Without proper sanitation practices, it can proliferate in a sprouting operation where it may contaminate food. Consuming food contaminated with
L. monocytogenes
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.
During the inspection, FDA collected a total of
(b)(4)
environmental samples (
(b)(4)
and
(b)(4)
) from your sprouting operation on January 29, 2019, and January 30, 2019.  The laboratory analysis yielded
(b)(4)
positive samples for
L. monocytogenes
, including from food contact surfaces.  Specifically,
(b)(4)
swab was collected from the underside of a stacked bucket that held bean sprouts.  The buckets containing bean sprouts were stacked on top of each other, and the underside of the stacked bucket that tested positive for
L. monocytogenes
was in direct contact with bean sprouts contained in the bucket directly beneath it. Further, the Florida Department of Agriculture and Consumer Services (FDACS) collected samples of your bean sprouts at various retail establishments on January 15, 2019, February 26, 2019, and February 27, 2019.
(b)(4)
of those samples were positive for
L. monocytogenes
.
Whole genome sequencing (WGS) analysis was conducted on the
(b)(4)
L. monocytogenes
isolates obtained from the positive FDA environmental samples collected during our inspection.  The WGS analysis of bacterial human pathogens provides high-resolution data as it measures each DNA position in a bacterial genome, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness.  The WGS data can also be used to infer the evolutionary relationships (or phylogeny) of a given set of isolates.  FDA’s WGS analysis of the
(b)(4)
isolates of
L. monocytogenes
found that they represented
(b)(4)
distinct strains.  The WGS analysis of the
(b)(4)
L. monocytogenes
isolates collected from bean sprouts by FDACS showed that
(b)(4)
and
(b)(4)
of those isolates were of the same strains found within the FDA environmental samples.  The high genetic similarity of the FDA and FDACS isolates and that they belong to the same strains suggests they likely came from the same source.  The presence of
L. monocytogenes
in your operation is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your operation to prevent contamination of food.
We received your written response dated March 21, 2019, outlining the corrective actions that you have taken in response to the environmental and product sample findings.  We acknowledge that you agreed on March 8, 2019, to recall a lot of your Organic Bean Sprouts.  We also acknowledge that you have stated that you will more frequently monitor the environmental samples that you collect.  We are unable to evaluate from your response, however, whether you conducted any extensive sampling or testing to verify that the contamination has been removed from your operation, including food contact surfaces and non-food contact surfaces.
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the Produce Safety regulation, 21 CFR Part 112:
1.    After your growing, harvesting, packing, or holding environment tested positive for
Listeria
species or
L. monocytogenes
, you did not conduct additional sampling and testing to determine whether the
Listeria
species or
L. monocytogenes
has been eliminated, as required by 21 CFR Part 112.146(c), and you did not perform any other actions necessary to prevent recurrence of the contamination, as required by 21 CFR Part 112.146(e).  Specifically, you received results from your environmental testing on December 14, 2018; January 9, 2019; and March 1, 2019; showing that your harvesting, packing, and holding environment tested positive for
L. monocytogenes
.  Additionally, some of your positive environmental samples were found in the same locations or on the same surfaces over time; for example, the December 14, 2018; January 9, 2019; and March 1, 2019; reports all stated that the bean sprout packing table tested positive for
L. monocytogenes
.  During our inspection, we also tested your growing, harvesting, packing, and holding environment and found samples positive for
L. monocytogenes
, including one from the bean sprout packing table.  These findings demonstrate that
L. monocytogenes
was not eliminated from your growing, harvesting, packing, or holding environment and demonstrate the recurrence of
L. monocytogenes
contamination.
We acknowledge your response dated March 21, 2019; however, we are unable to evaluate the adequacy of your corrective actions.  In your response, you stated that
(b)(4)
.  We are unable to evaluate from your response, however, the specific details regarding your
(b)(4)
or frequency, nor did you describe or submit environmental testing results to verify that your measures were effective.  We will evaluate the adequacy of your corrective actions at our next inspection.
2.    You did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce, as required by 21 CFR Part 112.123(d)(1).  Specifically, during the inspection, our investigator observed that white and yellow buckets used to hold and store harvested bean sprouts were cracked, with dark scores and chips on areas of the buckets that touch the bean sprouts.  The surface of these buckets had dark food residues in scored crevices.  Additionally, our investigator observed cracks and rough surfaces in the plastic panels inside the bean sprout growing bins.  Our investigator observed that one of the cracks in the growing bins had adhesive tape applied to the crack as a repair.  Our investigator also observed that the food contact surfaces of the blue conveyor belt used to transport harvested bean sprouts from the growing room to the packaging room was in disrepair, with a cracked, peeling surface and damaged and missing sections of material along the belt.
We acknowledge your response dated March 21, 2019; however, we are unable to evaluate the adequacy of your corrective actions.  Your response states that
(b)(4)
. Your response states that
(b)(4)
. Your response also states
(b)(4)
.  You further explained in your response that,
(b)(4)
.  Your response, however, does not state whether or how you will inspect and maintain the food contact surfaces of equipment and tools such as the buckets, barriers, bins, and conveyor belt as frequently as reasonably necessary to protect against contamination of covered produce.  We will evaluate the adequacy of your corrective actions at our next inspection.
3.    You did not aseptically collect samples of spent irrigation water, as required per 21 CFR Part 112.147(b).  Specifically, our investigator observed a laboratory employee collecting spent irrigation water samples in a white tray placed under the flow of water from the growing bins. The employee then transferred the water into glass containers with plastic lids.  The white trays and other supplies were stored in a cart as the employee traveled through the operation but were open and not protected to prevent contamination from the environment.
We acknowledge your response dated March 21, 2019; however, we are unable to evaluate the adequacy of your corrective action.  Your response states that
(b)(4)
; however, we are unable to evaluate from your response how you are maintaining the sterility of the white trays.  We will evaluate the adequacy of your corrective actions at our next inspection.
This letter is not intended to be an all-inclusive list of the violations at your operation or in connection with your products.  You are responsible for ensuring that your operation operates in compliance with the Act and all implementing regulations.  You should take prompt action to correct all violations noted in this letter.  Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future.  You should include in your response documentation and any other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.  If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention:  Ramon A. Hernandez, District Director, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico  00901.  If you have questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at (813) 915-7948, or via e-mail at:
Laura.Kennedy@fda.hhs.gov
.
Sincerely,
/S/
Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations,
East Division IV
Content current as of:
11/12/2019
Regulated Product(s)
Food & Beverages