Inspections, Compliance, Enforcement, and Criminal Investigations

Elwood International, Inc. 9/27/18

 

  

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WARNING LETTER
CMS# 552203
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
September 27, 2018
 
Mr. Stuart Roll, Founder, Owner and Chief Executive Officer
Mr.  Richard F. Roll, Vice-President
Elwood International, Inc.
89 Hudson Street
Copiague, NY 11726-1521      
 
 
Dear Mr. Stuart Roll and Mr. Richard F. Roll:
 
The U.S. Food and Drug Administration (FDA) inspected your Ready-to-Eat (RTE) single serve condiment manufacturing and warehouse facility, Elwood International, Inc., located at 589 Hudson Street in Copiague, NY 11726-1521 from January 8 to February 6, 2018. This inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule [21 CFR Part 117] (CGMP & PC Rule) and the low-acid canned food regulations [21 CFR Parts 108 and 113] (LACF regulations). 
 
Based on FDA’s findings during the inspection, we determined that your food 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 contaminated with filth or rendered injurious to health. You may find the Act and FDA’s regulations through the links in FDA’s home page at www.fda.gov.
 
During the inspection, we collected a sample of your Elwood’s Fat-Free Low Sodium Ranch Dressing Artificial Flavor. Based on your firm’s practice of shipping this hermetically-sealed product in unrefrigerated conditions, combined with FDA sample results indicating product pH above 4.6 and water activity above 0.85, your Elwood’s Fat-Free Low Sodium Ranch Dressing Artificial Flavor is a low-acid food product, as defined by 21 CFR 113.3(n). The inspection revealed serious violations of the LACF regulations. These violations cause your low-acid food product to be adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. We acknowledge that your firm voluntarily recalled all lots of this product within expiry.
 
At the conclusion of the inspection, FDA issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. To this date, we have not received your firm’s response to the FDA-483.
 
Violations of the Low-Acid Canned Food requirements:
During inspection of your facility, FDA investigators observed a significant violation of the low-acid canned food regulations (LACF), Title 21, Code of Federal Regulations, Parts 108 and 113 (21 CFR 108 and 21 CFR 113) for foods. Specifically,
 
Your firm did not have personnel involved in retorts, thermal processing systems, aseptic processing and packaging systems, or other thermal processing systems, and container closure inspectors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner as required by 21 CFR 108.35(g). Specifically, you manufacture shelf stable RTE Elwood Fat-Free Low Sodium Ranch Dressing Artificial Flavor packaged in 12 g cups and no one at your firm has attended or completed a Better Process Control School.
 
Violations of the Current Good Manufacturing Practice requirements:
During inspection of your facility, FDA investigators observed the following significant violations of subpart B of the CGMP & PC rule:
 
1.    You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, during the inspection of your facility, FDA investigators observed the following evidence of insect and rodent activity:
 
On 01/08/2018 at the 3 N Oak Street Facility in the Production Room/Kitchen, Production Office, and Electrical Closet Areas
A.  One apparent dead rodent was observed to be approximately 3 feet from the West wall, in the middle of the floor, between both windows.
B.  Two apparent dead rodents were each observed to be on a white sticky trap in the Northwest corner of the production office, in front of the window adjacent to a tall, white plastic cabinet.
C.  Two apparent dead rodents were each observed to be on white sticky traps against the West wall, adjacent to the window in the Northwest corner.
D.  One apparent dead rodent was observed to be on a white sticky trap in the Northeast corner between a tall, white metal cabinet and a low-standing, black metal cabinet.
E.  One apparent dead rodent was observed to be on a white sticky trap in the Northeast corner in front of the low-standing black metal cabinet.
F.  15 intermingled rodent excreta pellets (REPs) were observed behind the low-standing black metal cabinet in the Southwest corner.
G.  10 REPs were observed on the white radiator next to the white plastic cabinet, in the Northwest corner.
H.  Too numerous to count (TNTC) REPs were observed on the floor along the production office wall shared with the Production Room/Kitchen. There were REPs in front of the low-standing, black metal cabinet located under yellow organization bins hung on the East wall.
I.  25 intermingled REPs were observed on the floor along the West wall of the Production Room/Kitchen between the door to the Employee Breakroom and the Batch Room area.
J.  15 REPs were observed under a wooden pallet intermingled with unknown white powder. The wooden pallet was located along the west wall of the Production Room/Kitchen between the door to the Employee Breakroom and the Batch Room area. The wooden pallet held several bags of (b)(4).
K.  Three intermingled REPs were observed to be on the windowsill located on the West wall of the Batch Room.
L.  Intermingled TNTC REPs were observed in the Northeast corner between the tall, white metal cabinet and the low-standing black metal cabinet.
M.  Two REPs were observed on the floor along the exterior North wall of the women’s bathroom, outside the door to the Production Office.
 
Physical sample #INV1025534 was collected from the Production Room/Kitchen, Production Office, and Electrical Closet Areasduring the inspection of your facility and was analyzed by our laboratory. Subs 1, 2 and 3 were collected from the “kitchen,” and subs 4, 5 and 6 were collected from the production office. All subs consisted of rodent excreta pellets found throughout these two areas. The analysis of this sample confirmed the material collected consisted of rodent excreta pellets. The analytical results for this sample confirm the presence of rodent activity within your facility.
 
On 01/08/2018 at the 89 Hudson Street – Food Warehouse
A.  Three apparent dead insects and one apparent dead cockroach were observed on a white sticky trap along the South wall, approximately four feet east of two red wires protruding from the concrete floor.
B.  13 apparent dead spiders and one apparent dead cockroach were observed on a white sticky trap located east of the door marked “EXIT” in the Southwest corner of the building.
C.  Three apparent dead cockroaches were observed on a white sticky trap in the Southwest corner of the building along the west wall.
 
On 01/08/2018 at the 99 Hudson Street – Food Warehouse and Unused Office Space
A.  50 intermingled REPs were observed scattered throughout the ½ bathroom located in the Northwest corner, sharing a wall with the ¾ bathroom.
B.  40 intermingled REPs were observed to be scattered throughout the hall closet located in the Northeast corner.
C.  50 intermingled REPs were observed scattered under the approximate four-inch gap beneath the kitchenette cabinets.
D.  One apparent dead rodent and seven apparent dead cockroaches, 15 cockroach excreta pellets, and approximately two dead insects were observed on a white sticky trap between the door of the ¾ bathroom and the North door leading to the Food Warehouse.
E.  25 intermingled REPs were observed scattered throughout the ¾ bathroom.
F.  Six apparent cockroach egg cases were observed along the West wall underneath and behind a wooden desk adjacent to the South door leading to the Food Warehouse.
G.  Two apparent dead cockroaches were observed on a white sticky trap approximately three feet from the South door leading to the unused office space.
H.  An unmarked box of orange-red colored powder was observed to have approximately five dead insects and four apparent egg cases inside. This unmarked box was located on a wooden pallet, on the floor along the West wall, four feet from the South wall garage door. In addition to one unmarked box, this pallet had one box (b)(4) and (b)(4) of “(b)(4).”
 
On 01/12/2018, your firm voluntarily destroyed the one unmarked box, the box of (b)(4), and the (b)(4) of “(b)(4) However, this immediate correction does not address corrective actions needed to prevent recurrence.
 
2.    Your plant is 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, our investigators observed the following:
 
At the 3 N Oak Street Facility
A.  On 01/08/2018 condensation from the ceiling and ceiling pipes was observed dripping throughout your facility. The condensate was observed falling directly onto the clear lidding film used on both Single Process Lines while one of the processing lines was packing ready-to-eat (RTE) Tartar Sauce into plastic ½ oz. cups, and the other “Jelly Packing Line” was filling RTE Strawberry and Grape Jelly stamped “0098 16:28.” Again on 01/17/2018, condensation from the same area of the ceiling was observed dripping onto the “Jelly Packing Line,” on the metal surface immediately adjacent to where exposed plastic ½ oz. cups were being filled with RTE Grape Jelly. On 01/12/2018, your firm voluntarily destroyed (b)(4) of Elwood Reduced Sugar Jelly in strawberry and grape flavor with lot # E-678-10 200-10 GM 0098 16:28. However, this immediate correction does not address appropriate corrective actions needed to prevent recurrence of the observed deficiency.
B.  On 01/08/2018 condensate was observed dripping onto the packaging film on the “Single Process Line” where RTE margarine was being packaged.
C.  On 01/08/2018 condensate was observed accumulating on a black pipe directly above Kettle (b)(4) that was manufacturing Mayonnaise, and a liquid was observed falling from the ceiling between Kettle (b)(4) and Kettle (b)(4). Condensate and liquid was observed on at least 11 boxes of a pallet of finished product of Winston Single Servings Mustard located at the Southeast corner in front of the garage adjacent to Kettle (b)(4).
D.  On 01/08/2018 a spinning fan on the ceiling directly above the “Jelly Packing Line” was observed to spray an unknown wet substance throughout the facility, while your firm was packing RTE Grape and Strawberry Jelly. This appeared to be due to the spinning fan being located adjacent to a leaky pipe.
E.  On 01/17/2018 condensate was observed dripping onto the lid of a sealed holding drum, into which RTE margarine was being pumped.
F.  On 01/19/2018 condensation and apparent rust was observed on the ceiling and in the uncovered ceiling light in the Batch Room, directly above where clean utensils were stored.
 
3.    Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food, as required by 21 CFR 117.80(c)(8). Specifically, the 3 N Oak Street Facility was not equipped with shatterproof lights or light fixtures in the food Production Room/Kitchen where food is exposed during manufacturing and packaging.
 
4.    You must maintain buildings, fixtures, and other physical facilities of 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).
 
At the 3 N Oak Street Facility
A.  The floors of the Production Room/Kitchen were observed to be pitted and flooded. 
Some areas were observed to be flooded with approximately two inches of a stagnant liquid substance.
B.  An approximately 4-5-inch hole, approximately 8 inches from the floor, was observed on the East garage door.
C.  A hole, approximately 2-3 inches in diameter, approximately 1 foot from the floor, was observed in the South wall behind Kettle (b)(4).
D.  The South garage door, adjacent to Kettle (b)(4), had an approximately 1.5-2-inch gap from the ground. An accumulation of ice was observed on the bottom of the garage door. A pallet of Winston Single Servings Mustard finished product was located directly in front of the South garage door.
E.  On 01/17/2018, the pistons on the Single Process line located nearest the South-East wall of the production area were observed to have an accumulation of food product after cleaning. The pistons were also observed in this condition on 01/19/2018.
F.  On 01/19/2018 after cleaning, an accumulation of food products from previous productions was observed inside the kettles, on the underside of the motor housing of the mixing blades, on the metal mixing blades themselves, and product transfer pipes.
 
 At the 99 Hudson Street – Food Warehouse
On 01/08/2018, the bottom right corner of the windowpane on the south exterior wall, directly west of a grey, metallic, utility pole attached to the building, was observed to have a detached windowpane leaving a gap in the window open to outside elements.
 
5.    Your plant did not have adequate sanitary facilities and accommodation for trash disposal, as required by 21 CFR 117.37(f). Specifically, during the inspection our investigators observed   throughout the 3 N Oak Street Facility, an accumulation of overflowing trash in the Northeast corner of the Batch Room along the wall of the Employee Breakroom. The trash was observed to be overflowing onto a pallet of raw materials adjacent to the large, plastic, gray trash bin.
 
6.    You did not conduct operations in accordance with adequate sanitation principles and take adequate precautions to ensure that production procedures did not contribute to allergen cross-contact and to contamination, as required by 21 CFR 117.80(a)(1) and (4).
 
A.  Our investigators observed on 01/17/2018 that while the single process lines were cleaned while the packaging film was still installed on the machines, water and sanitizer were observed splashing onto the film, a RTE food contact surface. This practice was observed again on 01/19/2018.
B.  Employees were observed on 01/17/2018 cleaning the lids of the holding drums used for storing mayonnaise, jelly, or salad dressing products by resting them on the floor and spraying them with steam water. The edges of the lid remained in contact with the floor during and after spraying with water. The floor had an accumulation of stagnant liquid and food residue which was observed directly contacting the lids.
C.  Employees were observed on 01/17/2018 placing the outlets of product transferring hoses inside the drains on the floor, to flush out the residual product. The hoses were then flushed with steam and water after being in direct contact with the floor drains and waste water. This practice was also observed on 01/19/2018.
D.  On 01/19/2018 an employee was observed washing stainless steel buckets on the floor, directly on top of the floor drain. These buckets are used to weigh ingredients during manufacturing.
 
7.    You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the conditions of use, as required by 117.35(b)(1). Specifically, on 01/17/2018, our investigators observed an employee diluting (b)(4). The supplier’s instructions are to dilute (b)(4). The employee was then observed using the mixture to clean equipment hoppers, kettles, and food contact surfaces.
 
8.    Your equipment and utensils were not designed and constructed to be adequately cleanable and maintained to protect against allergen cross-contact and contamination, as required by 21 CFR 117.40. Specifically, our investigators observed that your product transfer hoses used to transport various RTE products are not constructed in a way they can be thoroughly cleaned and be kept in a sanitary condition. Several of these hoses which were used to transfer mayonnaise and margarine were observed to have a red discoloration inside, which appeared to be accumulated product from previous productions of different products. Also, you do not have designated hoses for allergenic and non-allergenic products. During the inspection, your firm was observed handling the allergens of soy, eggs, and peanuts.
 
General Comments:
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products are considered low-acid canned foods or acidified foods, as defined in 21 CFR 113.3(n) and 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108, 113 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are low-acid canned foods or acidified foods, and comply with the applicable requirements of 21 CFR Parts 108, 113 and 114, including process filing, for those products that are determined to be low-acid canned foods and acidified foods.
 
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 LACF regulations, the CGMP & PC rule, and other applicable requirements. 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, seizure and injunction.
 
Note that, although not covered by this inspection, you are subject to the preventive control requirements (primarily located in subparts C and G) of the CGMP & PC rule.   Under those requirements, a covered food facility must 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 the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 USC §§ 342 and 343(w)).   Further, a covered food facility must have a written food safety plan that includes a written hazard analysis, and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary). Other requirements include employee training (subpart A) and recordkeeping (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations.
 
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 Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, please contact W. Martin Rennells at 518-453-2314 x1038 or william.rennells@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Ronald Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1

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