WARNING LETTER
Friendly's Manufacturing and Retail LLC
MARCS-CMS 590821 —
November 22, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Eric Beringause
Recipient Title
President and Chief Executive Officer
Friendly's Manufacturing and Retail LLC
2711 North Haskell Avenue
Suite 3400
Dallas
,
TX
75204
United States
Issuing Office:
Office of Human and Animal Food Operations East - Division 1
462 Welcome Center Road
Swanton
,
VT
05488
United States
Dear Mr. Beringause:
The United States Food and Drug Administration (FDA) inspected your Dean Foods company-owned Friendly’s Manufacturing and Retail LLC, ready-to-eat (RTE) food manufacturing facility, located at 1855 Boston Road, Wilbraham, MA 01095-1002 from July 29, 2019 to August 20, 2019. Your facility manufactures RTE food products including ice cream products (scrounds, sundae cups, decorated cakes), various syrups, and fudge. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR part 117). During the inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of
Listeria monocytogenes (L. monocytogenes)
, a human pathogen, in your facility, which matches the same strain found during FDA’s 2017 inspection. FDA’s inspection resulted in the issuance of an FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found during our inspection. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the RTE food manufactured in your facility is 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 it was prepared, packed or held under insanitary conditions whereby it 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
.
We received written responses dated August 15, 2019, and September 11, 2019, describing corrective actions taken and planned by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
Your hazard analysis did not identify a known or reasonably foreseeable hazard that requires a preventive control, as required by 21 CFR part 117.130(a)(1). Specifically, you did not appropriately evaluate environmental pathogens as required by 21 CFR part 117.130(c)(ii). You manufacture RTE food products that are exposed to the environment at several steps where the food could be contaminated with environmental pathogens, such as
L. monocytogenes
, and the food does not receive a subsequent control for environmental pathogens. Your “FSMA/FOOD SAFETY PLAN” issued on June 10, 2019, lists pre-requisite programs (PP) and Sanitation Standard Operating Procedures (SSOP), “PP1- Environmental Monitoring,” “PP3-current Good Manufacturing Practices,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “PP7-SSOPs,” at processing steps where food is exposed to the environment, as reasons that a hazard (e.g.,
L. monocytogenes
) does not require a preventive control. However, for RTE foods exposed to the environment, SSOPs are sanitation controls that are verified by environmental monitoring. These measures should not be considered when determining whether sanitation preventive controls are needed.  Environmental monitoring (e.g., Dean Foods’s corporate environmental monitoring program “PP1- Environmental Monitoring Preventive Control” and/or your facility specific “Pathogen Environmental Monitoring Program”) is needed to verify that environmental pathogens are being controlled by the sanitation control measures.
One environmental swab
collected from the floor area of
(b)(4)
during FDA’s 2019 inspection contained
L. monocytogenes
. (According to your Plant Manager, food products manufactured during   our  environmental swabbing were discarded.)  In addition,
L. monocytogenes
was found in seven environmental swabs collected during FDA’s 2017 inspection, including one that was also from the floor in
(b)(4)
. Further,
your firm’s environmental testing results from May 1, 2018, to July 5, 2019, for swabs collected from the WC4 area show several
Listeria
spp. positive swabs. Whole genome sequencing (WGS) of positive isolates detected in FDA’s environmental swabbing determined that the eight positive swabs collected during our 2017 and 2019 inspections contain the same strain of
L. monocytogenes
.
We advised you of those WGS results via a conference call on August 16, 2019. The presence of the same strain
of L. monocytogenes
over multiple years indicates that there has been a resident pathogen 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 by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.
Additionally, during FDA’s 2019 inspection, two environmental swabs were positive for
Listeria innocua
(
L. innocua
). One of the
L. innocua
swabs was collected from ice cream dripping from a valve on a freezer cycle in
(b)(4)
where Friendly’s brand strawberry shortcake sundaes were being manufactured. This location is adjacent to a drain where, in 2017, FDA isolated
L. monocytogenes
and
L. innocua.
The second
L. innocua
swab was collected from a floor drain in the
(b)(4)
area. This swab site was in the same location as a previous
L. monocytogenes
positive sample collected by FDA during our 2017 inspection. Additionally, your firm’s environmental testing results for swabs collected in the
(b)(4)
area showed multiple
Listeria
spp. positive swabs between January 10, 2018 to July 24, 2019.
In reviewing your firm’s environmental monitoring program, we note that you have repeatedly found
Listeria spp
. throughout your processing facility. Specifically, from January 2019 through July 2019, 13.4% of all swabs taken were positive for
Listeria spp
.; from January 2018 through December 2018, 20.9% of all swabs taken were positive for
Listeria spp
.; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for
Listeria spp
. Your 2017 environmental monitoring findings were discussed with your firm during our 2018 Regulatory Meeting.
You committed to performing corrective actions in written responses dated August 15, 2019, and September 11, 2019. Your September 11, 2019, corrective action response indicates that your food safety plan’s hazard analysis was updated to identify environmental pathogens as a hazard requiring preventive controls and identified sanitation controls (Sanitation Standard Operating Procedures and Sanitation Preventive Controls-PC2 and Good Manufacturing Practices- PC7) to address the hazard. In your written responses, you indicate that you have taken a number of corrective actions, which include performing an intensified cleaning and sanitizing of your production area; conducting a root cause analysis in response to our environmental findings; shutting down
(b)(4)
to perform targeted remediation work, clean and sanitize, and conduct verification swabbing; conducting a refresher training for employees; and performing intensified cleaning of all utensils, work surfaces, and equipment. We recommend that you continue to implement these corrective actions to ensure that L. monocytogenes does not contaminate your RTE food products. We will verify the implementation and adequacy of these corrective actions during our next inspection.
2. 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). As evidenced by environmental findings that indicate a resident strain of
L. monocytogenes
in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not 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).
As noted above, your September 11, 2019, corrective action response identified sanitation controls (Sanitation Standard Operating Procedures and Sanitation Preventive Controls-PC2 and Good Manufacturing Practices- PC7) to address the hazard of environmental pathogens such as L. monocytogenes.  The corrective actions include intensified daily cleaning throughout the plant, shortened production schedules and coordinated cleaning programs among the Work Centers, which could allow for more cleaning time and reduce foot traffic and water splash issues; testing each production line during production to determine negative results; and the hiring of additional Quality Assurance technicians and sanitarians to improve the environmental monitoring plant-wide.  We will verify the implementation and adequacy of these corrective actions during our next inspection.
Current Good Manufacturing Practice (Subpart B):
1. You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Specifically, your sanitation control procedure, “PP3 Current Good Manufacturing Practices,”
(b)(4)
products or product contact surfaces. Gloves must be maintained intact, clean and in sanitary condition.”  However, the following practices were observed:
a. An employee in charge of mixing
(b)(4)
did not wash and sanitize his hands and did not wash, sanitize, or change his gloves after touching scoop handles that contained
(b)(4)
, opening boxes of
(b)(4)
, and transferring
(b)(4)
to the decorating lines.
b. Your corporate Quality Assurance Director was observed using his bare hands to push partially overturned RTE sundae cups through the
(b)(4)
machine. Afterward your corporate Quality Assurance Director was observed licking ice cream off his bare hands.
These types of practices are a repeat observation from our 2017 inspection. Your firm’s corrective action response received on September 11, 2019, addresses the immediate concerns as well as outlines long term corrective actions that you plan on implementing, including re-training your employees on the usage of gloves and updating your RTE Brill handling process to address this observation. We will verify the adequacy of these corrective actions during our next inspection.
2. Your plant was not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR § 117.20(b)(4). Specifically,
(b)(4)
on
(b)(4)
were observed with continuously dripping condensate from overhead pipes collected over the single filler heads while filling containers with RTE ice cream. Condensate was also observed dripping continuously from overhead manifold pipes on
(b)(4)
onto floors below where it pooled, and these areas were observed with high foot traffic and pallet traffic.  Condensate continuously dripped from overhead pipes and collected on a plexiglass shield placed above the assembly line on
(b)(4)
. Condensate was observed to occasionally drip from one corner of the shield onto to the assembly line and onto the outerwear of employees decorating RTE cakes and onto the RTE topping hopper.
Condensate deficiencies are a repeat observation from our 2017 inspection. Your firm’s corrective action responses received on August 15, 2019 and September 11, 2019, address the immediate sanitation concerns as well as outline long term corrective actions that you plan on implementing, including consulting with a third-party expert to assist in assessing how to implement better condensate control within your environment and implementing corrective action measures based on your findings. We will verify the adequacy of these corrective actions during our next inspection.
3. You did not clean your utensils and food contact surfaces of equipment as frequently as necessary to protect against contamination of food, as required by 21 CFR § 117.35(d). Specifically:
a. Your sanitation control procedure, “SSOP1 Cleanliness of Food Contact Surfaces,” states that “all food contact surfaces shall be cleaned and sanitized daily or as used.” However, the following practices were observed:
i. Cake molds had food debris (white and chocolate ice cream) from previous use when exiting the dishwasher. Employees continued to use these molds without sending the molds back through the dishwasher.
ii. An employee used a metal ruler to push RTE products into a topping hopper and then placed the ruler on an unclean work cart. This ruler was used throughout production operations and was not observed being cleaned and sanitized.
Your firm’s corrective action responses include actions your firm will take to address these findings which include updating your Sanitation Preventive Controls -PC2 to require that molds and RTE surfaces in cake production be
(b)(4)
at
(b)(4)
; and implementing policies that only devices constructed from
(b)(4)
material that have been cleaned and sanitized may be used to push RTE product down hoppers and for other food contact activity. We will verify the adequacy of these corrective actions during our next inspection.
4. You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically:
a. Your SOP “PP3 Current Good Manufacturing Practices” states that “cleaning and sanitizing of utensils and equipment should be carried out in a manner that prevents contamination of raw material, food packaging supplies, and finished product.” However, we observed the use of unrestrained high-pressure hose during cleaning and sanitizing of floors and equipment leading to overspray in active lines producing RTE ice cream products, which had the potential for contamination of these products. Specifically,
i. Overspray was observed during equipment and floor cleaning activities on
(b)(4)
adjacent to production activities on
(b)(4)
where an employee was observed routinely opening the lids of the
(b)(4)
mixing vats to monitor mixing of pasteurized chocolate mix.
ii. Overspray was observed during equipment and floor cleaning activities on
(b)(4)
adjacent to production activities on
(b)(4)
filler line and fruit feeder line with a plastic curtain divider in between.  This high-pressure hose usage resulted in overspray from unclean equipment to aerosolize, causing the mist to rise above the curtains towards the fruit feeder where a production employee was routinely opening the fruit feeder hopper to add pecans on the
(b)(4)
line.
iii. Employees were observed using high pressure hoses during the
(b)(4)
cleaning activities on
(b)(4)
, which caused overspray onto the
(b)(4)
cloths covering RTE
(b)(4)
vanilla icing.
iv. Employees were frequently observed handling hoses to wash down spills and excess food debris from the floors on
(b)(4)
during ongoing production activities which resulted in overspray from the floors onto RTE chocolate fudge fillers and RTE fruit feeders containing nuts.
Your firm’s corrective action responses outline corrective actions to address the immediate sanitation concerns observed during the current inspection, including restricting the use of high-pressure hoses near in-use production lines. Additionally, in the longer-term, you will replace these high-pressure hoses with ones that are high flow/low pressure, and you will re-train your employees on how to properly use this piece of equipment.  We note that the use of spray hoses next to in-process product was documented by our investigator during FDA 2017 inspection Your response to FDA’s 2017 inspection findings also stated that you would re-train your employees.  As evidenced from our current inspection, your past corrective actions do not appear to have long lasting or effective results. We strongly encourage you to reassess and implement programs that are effective.
b. Our investigators observed the following practices involving pails and brushes which do not protect against contamination of food, food-contact surfaces, and food-packaging materials
i. Green pails designated for finished products/ingredients were used to hold overflow ice cream during production and were placed directly below pipes from which condensate dripped into them. These pails were also observed being emptied into a discarded product vat during which the rim and exterior of the pails came into contact with the discarded food and the food vat and then returned to the production line without any cleaning or sanitizing.
ii. Employees were observed moving orange pails to multiple surfaces within the production environment without cleaning or sanitizing the pails between uses. These surfaces include, floors, RTE product work counters, and the assembly conveyor.  In addition, employees were observed using yellow brushes designated for “exterior surfaces,” such as wheels and floors, to scrub areas around food contact surfaces such as conveyor belts, scales, work tables.
Your firm’s corrective action responses include actions your firm will take to address these findings, which include outlining specific uses for your green and orange pails and having a schedule to clean and sanitize your pails which will be monitored in your daily production records. We will verify the adequacy of these corrective actions during our next inspection.
5. You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR § 117.80(c)(2).  Specifically,
a.
(b)(4)
cloths were observed being used and re-used without adequate cleaning and sanitizing of the cloths. We observed
(b)(4)
cloths being used in various activities during production, including wiping down condensate, conveyors, scales, and RTE cake decorating stands; covering food; and wiping off excess food from the sides of cake molds. For example, we observed an employee using
(b)(4)
cloths to wipe condensate on pipes and then using the same cloth to touch cakes while decorating.
b. Disassembled parts and pipes from the
(b)(4)
filler were stored inside the handwashing sink in
(b)(4)
. During
(b)(4)
sanitation,
(b)(4)
guards disassembled from the
(b)(4)
filler were stored on wet production floors next to a floor drain with high foot traffic at the
(b)(4)
line.
c. Hoses used for sanitizer and water were not clearly marked and were observed being placed directly on wet floors, over flavor vats, and on top of multiple product contact work surfaces.
Your firm’s corrective action responses include actions your firm will take to address these findings which include using
(b)(4)
towels only throughout the plant for equipment, pipes, and other non-food contact surfaces; updating your written  programs, SSOP 1 Cleanliness of Food Contact Surfaces and Current GMPs-PC-7; and identifying your sanitation hose
(b)(4)
. We will verify the adequacy of these corrective actions during our next 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 that 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 by the FDA without further notice, including, without limitation, seizure and injunction.
Additional Comments:
After reviewing the documentation collected during our inspection and your corrective action responses, we have the following comments about your operation: Your facility manufactures various ice cream and ice cream products with different allergen profiles on the same day and on shared equipment. Your revised hazard analysis contained in your “FSMA/FOOD SAFETY PLAN” updated  on September 9, 2019, lists preventive control programs (PC) and Sanitation Standard Operating Procedures (SSOP), “PC2- SSOPs,” “PC-10-Supplier Verification,” “SSOP1- Cleanliness of Food Contact Surfaces,” and “SSOP7- Protection from Adulteration” at processing steps where RTE food is exposed to or may come into contact with shared equipment and utensils, as reasons that allergens do not require a preventive control.  The justification that allergen hazards do not require preventive controls describes control measures for allergens. These controls should not be considered when determining whether sanitation preventive controls are needed.
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.  Reinspection-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.  If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.  In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention:  Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, 462 Welcome Center Road, Swanton, VT 05488.  If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or by email at
scott.loughan@fda.hhs.gov
.
Sincerely,
/S/
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
Enclosures:
FDA-483 dated August 20, 2019 (Friendly’s Manufacturing and Retail LLC, Wilbraham, MA)
Cc:
Mr. Jon Heussner, Plant Manager
Friendly’s Manufacturing and Retail LLC
1855 Boston Rd.
Wilbraham, MA 01095
Content current as of:
12/10/2019
Regulated Product(s)
Food & Beverages