WARNING LETTER
Hans Kissle Company, LLC
MARCS-CMS 584080 —
September 24, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Signature Requested
Product:
Food & Beverages
Recipient:
Recipient Name
Kenneth R. Venti/Robert C. Lijana
Recipient Title
President/CEO - Director of Quality Control and Food Safety
Hans Kissle Company, LLC
9 Creek Brook Drive
Haverhill
,
MA
01832-1548
United States
Issuing Office:
Division of Human and Animal Food Operations East I (HAFE1)
One Winner’s Circle
Albany
,
NY
12205
United States
Dear Mr. Venti and Mr. Lijana:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) salads and RTE prepared foods manufacturing facility located at 9 Creek Brook Drive, Haverhill, MA 01832-1548 from March 9 through April 5, 2019.  During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule).  Additionally, FDA collected environmental samples from various areas of your processing facility. FDA laboratory analysis of the environmental swabs found the presence of
Listeria monocytogenes
(
L. monocytogenes
), a human pathogen, in your facility, including the same strain found during FDA’s 2017 and 2018 inspections. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the RTE foods manufactured in your facility 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.
In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at
http://www.fda.gov
.
FDA’s inspection resulted in the issuance of an FDA Form 483 (FDA-483), Inspectional Observations, on April 5, 2019, listing deviations found during our inspection. You responded to the positive
L. monocytogenes
sample findings on April 8 and May 31, 2019, and to the FDA Form 483 on April 26, 2019.  Your responses included a summary of corrective actions taken and planned by your firm. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis, and Risk-Based Preventive Controls (Subpart C):
1. You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)) to comply with 21 CFR § 117.135(a)(1).
a. In your food safety plan, you identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard. However, as evidenced by environmental findings that indicate a resident strain of
L. monocytogenes
in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen
L. monocytogenes
, as required by 21 CFR §§ 117.135(a)(1) and (c)(3).
Three (3) environmental swabs collected by FDA during our 2019 inspection were positive for
L. monocytogenes
, including
(b)(4)
positives. Furthermore, one (1) environmental swab collected during our 2018 inspection revealed
L. monocytogenes
in
(b)(4)
one location within your facility, and three (3) environmental swabs collected during our 2017 inspection revealed
L. monocytogenes
in three (3) locations, one of which
(b)(4)
location. Whole Genome Sequencing (WGS) of isolates detected in the FDA environmental samples identified six (6) isolates with the same strain of
L. monocytogenes
. Specifically, the same strain of
L. monocytogenes
was identified in three (3) isolates from environmental samples collected during the 2019 inspection, one (1) isolate collected from your facility in April 2018, and two (2) isolates collected from your facility in September 2017.  In addition, the strain matches one clinical blood isolate collected in September 2018, which indicates this strain has the capability of causing human illness. A second strain of
L. monocytogenes
was only seen at your facility in 2017. The presence of the same strain of
L. monocytogenes
over multiple years indicates that there has been a resident pathogen or harborage site in your facility since 2017.
These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent
L. monocytogenes
in your facility. Once
L. monocytogenes
is 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 survive and grow to take such corrective actions as necessary to eradicate the organism and prevent the organism from being re-established in such sites.
Furthermore, analysis of environmental samples collected during the current inspection isolated nine (9) swabs with non-pathogenic
Listeria
species, including
Listeria innocua
,
Listeria grayi
, and
Listeria welshimeri
located in the Main Production Room of your facility. The finding of these organisms indicates that conditions are suitable for survival and/or growth of
L. monocytogenes
.
Your written responses outline the corrective actions you plan to take, which include identifying a root cause, implementing new equipment SOPs, intensified cleaning and sanitizing along with intensified environmental swabbing, employee training on cross-contamination issues and equipment maintenance/leaks, developing new cleaning procedures and equipment sanitation procedures, hiring consultants, and modifying employee traffic and process flow.  We will verify the adequacy of your corrective actions during a future inspection.
b. You did not implement the written sanitation control procedures identified in your SSOP entitled “SSOP-003 Clean Equipment/Tote & Bowls Segregation,” as evidenced by the following:
• Your procedure states that “
(b)(4)
are to be used in
(b)(4)
and equipment.” However, on 3/20/2019, a sanitation employee was observed wheeling clean bowls and bins out of the Salad Wash Room.  The rims, bowls and handles of the cleaned bowls and bins were observed to come in contact with unclean bowls and bins that were staged in the same area waiting to be cleaned.
We will verify the adequacy of your corrective actions during a future inspection.
c. You did not implement the written sanitation control procedures identified in your SSOP entitled “SSOP-002 Ongoing Operational Sanitation SOP May 3, 2018 Version: [1]” as evidenced by the following:
• Your procedure lists steps to follow for cleaning and sanitizing equipment, totes and bowls that include a “
(b)(4)
” procedure. On 3/21/2019, the
(b)(4)
were only
(b)(4)
and then
(b)(4)
using
(b)(4)
during a product changeover from seafood salad to macaroni salad and curry chicken salad to tuna supreme, respectively. The
(b)(4)
was not used on the equipment during the cleaning process.
• Your procedure states in part that “The Sanitation crew is not allowed to make physical contact with any food contact surfaces.” On 3/20/2019, a Sanitation employee was observed sweeping food debris into a floor scooper and then placing his foot on an adjacent cart containing a stack of food contact metal trays.
Your responses outline the corrective actions you plan to take or have taken in response to this violation which includes revising your SSOPs and segregating the “washroom,” including removing unused/stored stainless steel equipment to create a larger footprint in the room to improve traffic flow (i.e., bowls and totes being wheeled into the room for cleaning, and then being wheeled out after cleaning), as well as creating a visual barrier to identify areas for dirty equipment and just cleaned equipment. We will verify the adequacy of your corrective actions during a future inspection.
2. You did not implement your supply-chain program, as required by 21 CFR § 117.405(a). Specifically, your "SQP-037 Approved Supplier Verifications Program July 2, 2018 Version: [4]" states that Certificate of Analysis (CoA) “must be received prior to or on the date of ingredient delivery for all ingredients unless expressly exempted by Hans Kissle QA” and must contain “physical, chemical and microbiological test results for the specific lot number or code of the product.” It was observed that you do not receive CoA’s for RTE/refrigerated diced vegetables and RTE/refrigerated feta cheese that are used in the production of RTE Aegean Greek Pasta Salad. Although you indicated that you have an “exempt list,” these suppliers were not named on this list.  Additionally, no further kill step is applied to the diced vegetables and feta cheese in the production of RTE Aegean Greek Pasta Salad.  Note that when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, the appropriate default supplier verification activity is an onsite audit of the supplier (see 21 CFR 117.430(b)(1)).
Your responses outline the corrective actions you plan to take in response to this violation, which include revising your Approved Supplier Program (SQP-037). We will verify the adequacy of your corrective actions during a future inspection.
Current Good Manufacturing Practice (Subpart B)
1. You failed to conduct all food manufacturing, processing, packing and holding under conditions and controls necessary to minimize the potential for growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food, as required by 21 CFR §117.80(c)(2). Specifically, on 3/21/2019,
(b)(4)
containing bags of RTE vegetables, including one (1) open bag of RTE carrots and one (1) torn bag of cucumbers, were staged on the floor of the hallway
(b)(4)
room.  This area was observed to be a high employee and equipment traffic area.  These bags of RTE vegetables are removed from their outer boxes in the hallway and placed onto plastic pallets or plastic totes adjacent to this area,
(b)(4)
was being washed and sanitized using
(b)(4)
that occasionally sprayed beyond the
(b)(4)
into the area where the vegetables were stored.
In addition, it was observed that it is your regular production practice to wheel unclean bowls and bins from the Main Production Room into the Salad Wash Room and conversely to wheel clean bowls and bins back into the Main Production Room through the same entrance/exit door. The Salad Wash Room floors were observed to be wet, have organic debris and the entrance/exit door was not equipped with a sanitizing control. After being wheeled across the wet floor, these bins were observed to be hoisted and tilted to dump product into various mixers and filler hoppers. On 3/20/2019 and 3/21/2019, when the bins were tilted, moisture and food debris were observed to drip from the bin hoisting equipment and the bin wheels into various mixers and RTE product including the
(b)(4)
, and
(b)(4)
.
Your April 8, April 26 and May 31, 2019 written responses outline the corrective actions you plan to take or have taken, which include evaluating your tote dumping procedures and implementing new equipment SOPs. We recommend that you continue to identify potential harborage sites and source(s) of the organism in your processing environment and implement the necessary methods and controls to ensure
L. monocytogenes
does not contaminate your RTE food products. We will verify the effectiveness of your corrective actions during a future inspection.
2. You did not maintain buildings, fixtures, and other physical facilities in your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR §117.35(a).  Specifically, during the most recent inspection of your facility, the following equipment conditions were observed in areas where there is significant handling of RTE product and employee movement:
• On 3/19/2019, gaskets around the
(b)(4)
carrying RTE egg salad from
(b)(4)
were leaking, and significant amounts of RTE egg salad was oozing out.
• On 3/19/2019 and 3/20/2019, gaskets around the
(b)(4)
carrying RTE potato salad from
(b)(4)
were leaking.
• On 3/21/2019, gaskets around
(b)(4)
carrying RTE potato salad from
(b)(4)
to
(b)(4)
were leaking, and significant amounts of RTE potato salad was oozing out.
• On 3/21/2019, gaskets and connections on
(b)(4)
carrying RTE macaroni salad were leaking, and significant amounts of liquid from the RTE macaroni salad was oozing out. One of the connections on pipes feeding
(b)(4)
and
(b)(4)
from
(b)(4)
was approximately 2 inches off the floor.
• On 3/19/2019, clear plastic film was wrapped around one end of the piston pump that assists in depositing product from the filler head onto containers on
(b)(4)
. Additionally, on 3/21/2019, clear plastic film was wrapped around one end of the piston pump that assists in depositing product (RTE macaroni salad) from the filler head onto containers on
(b)(4)
. An employee stated that the plastic film prevented the leaks on the pistons from spraying product around his work area.
Your responses outline the corrective actions you plan to take in response to these violations, which include replacing all faulty gaskets, O-rings, and flange seals from all RTE production lines, including
(b)(4)
fillers and pumps; as well as amending your line-checks to ensure line operators are accountable for leak checks.  We will verify the adequacy of your corrective actions during a future inspection.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products.  You are responsible for ensuring your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws.
You should take prompt action to correct the violations noted in this letter.  Failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
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 non-compliance 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)]. 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur.  In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections.  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: W. Martin Rennells, Compliance Officer, One Winner’s Circle, Suite 110, Albany, NY 12205.  If you have questions regarding any issues in this letter, please contact Mr. Rennells at
518-453-2314
x 1038 or
willliam.rennells@fda.hhs.gov
.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1
Content current as of:
10/08/2019
Regulated Product(s)
Food & Beverages