EPI, LLC. 8/31/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863

 

August 31, 2011

 

WARNING LETTER

 

CHI-09-11

 

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

 

Mr. Louis Tenore, Jr.

Owner

EPI, LLC

100 East Street

Poplar Grove, Illinois 61065-9787

 

Dear Mr. Tenore:

 

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 100 East Street in Poplar Grove, Illinois, on November 2, 8, 18, and 29, 2010.  Our investigators documented serious deviations from the current Good Manufacturing Practice (cGMP) requirements for manufacturing, packaging, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).  The inspection revealed that conditions in your facility have caused the food products manufactured and stored there to be 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)] because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.  You may find the Act, guidance, and additional information regarding the regulations through links in FDA's home page at www.fda.gov.

 

Our inspection of your facility revealed the following cGMP deviations:

1. You do not use water which is safe and of adequate sanitary quality in food and food-contact surfaces, to comply with 21 CFR 110.37(a) , which specifies that running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. During the inspection, our investigators documented the following:

• Un-tested well water is used to manufacture finished food products.
• Hot water was not available during the inspection.

2. You do not have plumbing adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2). Specifically, on 11/2/201, a sump pump was observed pumping water through a black corrugated sump hose to an open sewer pipe. Sewage was observed spraying out of the hose along its entire length and spraying throughout the production room.

3. Your facility’s plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils and therefore does not comply with 21 CFR 110.37(b)(3). Specifically, four faucets were observed mounted on poles with a hose attached that were not protected with any backflow prevention device in production area of the facility where Ready-To-Eat (RTE) food products are manufactured. The faucets for supplying water to each of the kettles are installed below the flood level rim.

4. Your facility’s plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2) The production hose used to transfer drainage and waste materials from the open drainage pit in the center of the room to the open floor drain in the cherry processing room is connected directly to the sewer line. During the inspection, the hose was leaking and spraying waste water and other materials across the cherry processing room floor.

5. Your facility’s plumbing is not adequately installed and maintained to provide adequate floor drainage to comply with 21 CFR 110.37(b)(4). Specifically, on 11/2/2010 three separate sump pits located in the production room were not draining and pooling sewage was observed in and around each of the sump pits. The concrete floor around all the drains throughout the facility is damaged, which allows sewage to pond on the floors in all production areas.

6. You do not provide employees with readily accessible and adequate toilet facilities to comply with 21 CFR 110.37(d). Specifically, the toilet facilities are inadequate and are only usable by employees when management turns the water on to that location.   Moreover, the toilet facilities were not maintained in a sanitary condition to comply with 21 CFR 110.37(d)(1). The bathroom sink was soiled with iron deposit, mold and grime.

7. You do not keep toilet facilities in good repair to comply with 21 CFR 110.37(d)(2). There is only one functional toilet located in the facility. The one functional toilet does not have a functional flush lever.

8. You have toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination, which is a violation of 21 CFR 110.37(d)(4). Specifically, there are no outer doors for the bathroom facility and the two individual toilet room doors were both open and exposed to the coconut processing area.

9. You do not provide hand washing and hand sanitizing facilities at each location in the plant where needed to comply with 21 CFR 110.37(e)(1). Our investigators observed the following:

• There were no hand washing or sanitizing facilities in the cherry production or cherry picking rooms where maraschino cherries are manufactured.
• No operational hand washing facilities were available in the coconut processing room where ready to eat food products are handled by employees.

10. Your hand-washing facilities do not comply with 21 CFR 110.37(e), which requires hand-washing facilities to be convenient and be furnished with running water at a suitable temperature. Specifically, our investigators noted the following:

• There were no hand-washing sinks located in any production areas, including the cherry processing room, picking room, and coconut processing room.
• There was no running water available at the hand washing facility or at the shipping room sink for employees to have access to wash their hands.
• The hose located in the coconut processing room, which was observed being used by one employee to rinse off his hands after packaging (b)(4) was only capable of delivering cold water.

11. You do not have sanitary towel service or suitable hand drying devices to comply with 21 CFR 110.37(e)(3). Specifically, it was observed that there are no hand towels or hand drying devices located in the hand washing facility or at any location throughout the entire facility.

12. You do not have devices and fixtures such as water control valves designed and constructed to protect against recontamination of clean, sanitized hands to comply withy 21 CFR 110.37(e)(4). Specifically, investigators observed that the fixtures on the hand sink located in the employee bathroom contained iron-like deposits and mold-like residues. 

13. All reasonable precautions shall be taken to ensure that production procedures do not contribute to contamination from any source to comply with 21 CFR 110.80. However the following was observed: 

• Pumps and piping used for pumping products and re-circulating product are deteriorated with duct-type taping around the openings and seams.
• Hoses used to add water for soaking cherries are stored in direct contact with the insanitary concrete flooring. The hoses are in direct contact with in-process product are not sanitized prior to production.

14. Your facility does not have posted, readily understandable signs directing employees to wash and sanitize hands as appropriate to comply with 21 CFR 110.37(e)(5). Specifically, there are no signs posted throughout the entire facility directing employees to wash their hands as appropriate. 

15. Your employees do not wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time their hands may have become soiled or contaminated to comply with 21 CFR 100.10(b)(3). Our investigators observed the following:

• The firm's manager and an additional employee were observed manufacturing and packaging (b)(4). No hand-washing occurred before, during, or after the processes by the manager and only after the process by the other employee. Prior to this process both employees were observed performing other functions such as cleaning equipment, handling raw materials, and eating.

16. Your employees do not wear hair nets where appropriate to comply with 21 CFR 110.10(b)(6). Specifically, employees were not wearing hair nets or any hair restraint while manufacturing Maraschino Cherries.

17. You are required to provide your employees with suitable outer garments are not worn that protect against contamination of food, food contact surfaces, and food packaging materials to comply with 21 CFR 110.10(b)(1). Investigators observed that employees were not wearing outer garments during the manufacturing of (b)(4) to protect against the contamination of food, food-contact surfaces, or food packaging materials. Employees were observed performing multiple functions such as cleaning equipment, handling raw waste and raw materials prior to food handling of RTE foods.

18. Responsibility for compliance with 21 CFR 110 was not assigned to competent supervisory personnel as required by 21 CFR 110.10(d).

• Your facility managers have had no training or previous experience regarding food sanitation and during the inspection, demonstrated lack of knowledge through non-use and lack of availability of hand sanitizers or hand-washing facilities, improper storage and use of soiled non-food contact equipment during processing, improper storage of waste, improper storage or raw materials, improper use of cleaning detergents, and improper cleaning and sanitizing of processing areas and equipment.

19. You do not take proper precautions to protect food, food-contact surfaces, and food-packaging materials from contamination with microorganisms, filth, and extraneous material to comply with 21 CFRR 110.20(b)(2). This cannot be taken because of deficiencies in plant construction. Specifically, our investigators observed the following:

• Cracks and crevices in the floors, walls, and ceilings, as well as the external structure of the building.
• There were holes in windows located in the cherry processing room and a missing window in the picking room.

20. Your plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, food-packaging materials and your plant must be constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair to comply with 21 CFR 110.20(b)(4) . During the inspection of your facility, investigators observed the following:

• Rusted and dripping plumbing in the cherry processing area, picking area, and coconut processing area. On 11/02/2010, a plastic tarp was observed over cherry production kettle (b)(4). The tarp, covering three 8x8 ceiling shields over the (b)(4) cherry holding tanks, contained holes.
• Investigators observed buckets on the floor in the picking room that were being used to catch condensate and pouring water coming from overhead steam piping in the production area.
• The floors throughout the facility (including the storage room, cherry processing room, picking room, and coconut processing room) were porous and contained numerous cracks and crevices with deteriorated concrete exposing the aggregate and loose gravel.
• Walls and ceilings contained chipping and peeling paint in the storage, cherry processing, picking room, coconut processing room, hand-washing facility and there was mold-like residue on the walls located in the picking room and coconut processing room.

21. You do not provide adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically, our investigators observed the following:

• On 11/2/10, approximately twelve rodent-like excreta pellets (REP) were observed behind pallets of coconut located along the east-facing wall of the coconut processing room.
• On 11/02/2010, a gap of more than 1 inch was observed under the south facing delivery door and service door located in the storage room.
• On 11/02/2010, approximately 20 - 30 box elder bugs were observed behind mouse trap #8 located near the service door on the south wall of the storage room.
• Missing window panes for windows located in the cherry processing room and picking room contain no window coverings or screen to protect against pests.
• There was a live plant growing through the window located on the south side of the east wall located in the storage room that hung down at least 7 feet.

22. You do not properly store equipment, remove litter and waste, and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures to comply with 21 CFR 110.20(a)(1). Specifically, our investigators observed overgrown grass and weeds up to 18 inches in height around the entire perimeter of the processing facility. The overgrown weeds and grass will not allow for routine inspection of the facility and constitute a harborage area for pests.

23. You do not provide safety-type light bulbs and lighting fixtures suspended over exposed food to comply with 21 CFR 110.20(b)(5). Specifically, the lighting fixtures suspended directly over all the picking tables used to sort out cherries with pits, do not contain safety-type light bulbs or any other protective covering to eliminate glass fragments from direct contact with food. The overall lighting is inadequate throughout the facility.

24. You do not have adequate ventilation to minimize odors and vapors in areas where they may contaminate food to comply with 21 CFR 110.20(b)(6). Specifically, there is no ventilation in the toilet facilities to prevent odors and vapors from migrating out into food processing areas.

25. You do not clean and sanitize food-contact surfaces in wet-processing before use and after any interruption during which they may have been contaminated, to preclude contamination with microorganisms to comply with 21 CFR 110.35(d)(2). Specifically, there are no sanitizers located on the premises to adequately sanitize utensils and equipment before or after processing. Employees currently uses [(b)(4)] detergent to clean the cherry soaking tanks, sugar kettles, and picking tables, but equipment is not further sanitized prior to use.

26. You do not maintain buildings fixtures, and other physical facilities of the plant in a sanitary condition or keep them in repair sufficient to prevent food from becoming adulterated within the meaning of the act as required by 21 CFR 110.35(a). Food and food packaging materials left uncovered were being stored directly beneath leaking ceilings and ceilings with chipped and peeling paint and mold. Peeling paint, rust, and mold were observed on the walls and ceilings throughout the production area.

27. You do not conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces to comply with 21 CFR 110.35(a). Specifically, the chemical used in the cleaning process (b)(4) container was not identified, so that the proper storage conditions or use of this product on food-contact surfaces could be adequately followed by employees. 

28. Your facility does not have corrosion-resistant food contact surfaces to comply with 21 CFR 110.40(a). Specifically, on 11/02/2010, corrosion was observed within the tanks and kettles located in the cherry processing room used to manufacture Maraschino Cherries.

29.  Non-food-contact equipment in manufacturing and food handling areas is not constructed, so that it can be kept in a clean condition to comply with 21 CFR 110.40(c). Specifically, numerous pieces of equipment such as the measuring scale, picking tables, and concrete base of cherry soaking tanks are deteriorated and do not have smooth surfaces so as to be easily cleanable.

30. You do not store finished food under conditions that would protect against physical, chemical, and microbial contamination to comply with 21 CFR 110.93. Our investigators observed the following:

• Finished Maraschino Cherries being stored in your firm’s toilet facilities.
• Barrels of old and decaying cherry product were stored uncovered next to finished product.

You are required to investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.

 

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

 

Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.

 

 

Sincerely,

/S/

Scott J. MacIntire

District Director

 

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