Observations directly from inspection notes:
- firm did not have running water in either the ladies or men’s restrooms used by employees. Further, the toilets and hand washing sinks were not functioning, and there are no other sinks in your facility. used buckets, filled with water, to flush the toilets and wash their hands after using the restrooms. You informed our investigator that these buckets are prefilled with water at the hose bib where the water supply line was cut and placed in the restrooms for immediate use and others stored outside the restrooms as reserves to be used later. Further, you informed our investigator that these buckets are used interchangeably for toilet flushing and handwashing and that the buckets are not cleaned or sanitized.
- a wooden desk with dirt and green stains on it, being used as a food preparation table. You informed our investigator that the desk is not cleaned with detergent or sanitizer, and is sometimes wiped down with a paper towel and water from a bucket in the restroom.
- green leafy particles and brown dried debris on knives stored in a wooden desk. You informed our investigator that these knives are used to cut produce and were not cleaned after use, but are cleaned prior to being used again with a paper towel and water from a spray bottle.
- an orange and white cat was moving freely throughout the warehouse.
- rodent excreta pellets - multiple occurrences
- mold in coolers - multiple occurrences
- a stack of 5 pallets; a barrel; equipment, and tools that were rusted; and wood and debris were scattered within 3 feet of the west side of the facility where the trailer is located. Further, there were vines draped along the east and west walls, with high grass and weeds that engulfed the perimeter on the south, east and west.
- that the thermometer used in produce cooler #1, where you store vegetables, fruit, and other food articles, was not operational. Further, you informed our investigator that that this thermometer had never been calibrated and was not used for over ten years
- an apparent fetid odor of rot, in unrefrigerated produce cooler #3. You informed our investigator that this is where spoiled products and trash are stored, until taken to the dumpster located outside your facility. For example, a container of spoiled onions, cardboard boxes, and other foreign matter was observed scattered on the floor in the cooler. Further, you informed our investigator that produce cooler #3 has not been cleaned in years.
- an employee smoking a cigarette and grabbing onions with his bare hand from an unmarked box, to fulfill an order for a customer
FDA WARNING LETTER
16-PHI-07
June 23, 2016
Joseph G. Lavella, Co-Owner
Lavella Brothers
723 W. 3rd Street
Chester, PA 19013
Dear Mr. Lavella:
The U.S. Food and Drug Administration (FDA) inspected your multiple food warehouse, Lavella Brothers, located at 723 W. 3rd Street, Chester, PA, on May 4, 2016 through May 26, 2016. The inspection found significant violations of the FDA’s Current Good Manufacturing Practice (cGMP) regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the food products stored at your facility 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.
In addition, your facility is not registered with FDA as required by section 415 of the Act [21 U.S.C. 350d] and FDA’s regulations in 21 CFR Part 1, Subpart H. You can find the Act and its implementing regulations on FDA’s home page at www.fda.gov.
The serious cGMP violations noted during the inspection were outlined on a Form FDA-483, Inspectional Observations, and were issued to you at the close of the inspection. A copy is enclosed for your review. Those violations include the following:
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. Specifically, our investigator observed that your firm did not have running water in either the ladies or men’s restrooms used by employees. Further, the toilets and hand washing sinks were not functioning, and there are no other sinks in your facility. We note that you informed our investigator that you shut-off the water supply due to a leak in the piping that runs under the foundation of the building, and that there has been no water in the restrooms since January 2016.
We acknowledge that, on May 23, 2016, our investigator was informed that water was restored to the restrooms for the toilets and hand washing sinks. However, we continue to have concerns because this correction is a temporary fix and the water supply is being turned on and off at the main water supply line and the leak in the system has not been repaired. Further, we have serious concerns that your firm has been operating under these insanitary conditions since January 2016 and you only took action as a result of our inspection.
2. You did not take necessary precautions to protect against contamination of food, food contact surfaces and food packaging systems with microorganisms and foreign substances, as required by 21 CFR 110.10(b)(9). Specifically, since January 2016 your employees have used buckets, filled with water, to flush the toilets and wash their hands after using the restrooms. You informed our investigator that these buckets are prefilled with water at the hose bib where the water supply line was cut and placed in the restrooms for immediate use and others stored outside the restrooms as reserves to be used later. Further, you informed our investigator that these buckets are used interchangeably for toilet flushing and handwashing and that the buckets are not cleaned or sanitized.
We acknowledge that, on May 26, 2016, our investigator was informed that the buckets were no longer being used and they have been discarded. However, we have serious concerns that your firm has been operating under these insanitary conditions since January 2016, and you only took action as a result of our inspection.
3. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). Specifically, food-contact surfaces were not adequately cleaned as evidenced by:
a. On May 12, 2016, our investigator observed a wooden desk with dirt and green stains on it, being used as a food preparation table. You informed our investigator that the desk is not cleaned with detergent or sanitizer, and is sometimes wiped down with a paper towel and water from a bucket in the restroom.
b. On May 18, 2016, our investigator observed green leafy particles and brown dried debris on knives stored in a wooden desk. You informed our investigator that these knives are used to cut produce and were not cleaned after use, but are cleaned prior to being used again with a paper towel and water from a spray bottle.
4. Your equipment must be of such material and workmanship as to be adequately cleanable and must be properly maintained, to comply with 21 CFR 110.40(a). Specifically, throughout the inspection our investigator observed that the wooden desk, used as a food preparation table, cannot be adequately cleaned. It is made of a porous and absorbent material, and has a ripped, black plastic mat stapled and nailed to the tabletop which fails to cover a large section of the tabletop and is not regularly replaced.
We acknowledge that, on May 26, 2016, our investigator observed a new removable table top made of a non-porous, non-absorbent material that can be adequately cleaned was fitted over the old desk.
5. Your firm failed to take effective measures to exclude pests from the processing area, as required by 21 CFR 110.35(c). Specifically, our investigator observed:
a. On May 4, 5, 12, and 13, 2016, an orange and white cat was moving freely throughout the warehouse. Further, you informed our investigator that the cat was from outside and that you allowed it to enter the building.
b. On May 5, 2016, there were at least (b)(4) shiny wet apparent rodent excreta pellets observed in the southwest corner of produce cooler #1, in a white box containing a 5 pound bag of (b)(4) Sun-Dried Tomatoes, with what appeared to be a gnaw mark into the bag. On May 5, 2016, there were at least (b)(4) dull hard apparent rodent excreta pellets alongside the southwest wall in produce cooler #1, approximately 4 inches from a 5 gallon container of (b)(4) deli pickles, “lot # (b)(4)”.
c. On May 5, 2016, there were at least (b)(4) hard apparent rodent excreta pellets alongside the southeast wall in produce cooler #1, approximately 3 inches from a 25 pound box of fresh cucumbers.
d. On May 5, 2016, there were (b)(4) dull hard apparent animal excreta, (b)(4) that were approximately 1 to 1-1/2 inches in diameter, and (b)(4) approximately 3 inches in length. The apparent animal excreta was approximately 6 inches from a pallet containing 5/24 oz. plastic containers of (b)(4) basil.
e. On May 26, 2016, we acknowledge that you disposed of the (b)(4) Sun-Dried Tomatoes, and that the (b)(4) basil was added to a list of items to be voluntarily destroyed when the rodent excreta was brought to your attention. However, we are concerned that you informed our investigator that your firm has not had any pest control services performed in the facility for over (b)(4), due to the service being too costly.
6. Your firm failed to maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). Specifically, our investigator observed what appeared to be a black moldy substance in the following areas:
a. Produce cooler #1, along the north, west, east, and south walls where fruit, vegetables, and other food articles were stored for customers, until pickup. For example, there was a box consisting of (b)(4) heads of green leaf lettuce, placed directly against the east wall that was open and exposed to where the moldy substance appeared.
b. Produce cooler #2, along the north, west, east, and south walls. This cooler is unrefrigerated and used as a staging area for customer pickup. A pallet of 9/50 pound bags of (b)(4) brand potatoes were stored directly against the wall where the moldy substance was located. In addition, our investigator reported a musty smell in produce cooler #2.
We acknowledge that, on May 26, 2016, our investigator observed that the walls in produce cooler #1 were cleaned, painted, and treated with (b)(4) Professional Instant Mold Stain & Mildew Stain Remover with Bleach. However, we are concerned that your firm was storing food articles in this cooler with mold on the walls. Further, you informed our investigator that the ceiling in produce cooler #1 may leak during heavy rain.
7. Your firm failed to properly store equipment, or cut weeds or grass within the within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigator observed a stack of 5 pallets; a barrel; equipment, and tools that were rusted; and wood and debris were scattered within 3 feet of the west side of the facility where the trailer is located. Further, there were vines draped along the east and west walls, with high grass and weeds that engulfed the perimeter on the south, east and west.
8. You do not have an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment, used to store food capable of supporting the growth of microorganisms, as required by 21 CFR 110.40(e). Specifically, on May 5, 2016, our investigator observed that the thermometer used in produce cooler #1, where you store vegetables, fruit, and other food articles, was not operational. Further, you informed our investigator that that this thermometer had never been calibrated and was not used for over ten years.
We acknowledge that, on May 26, 2016, our investigator observed a new thermometer in produce cooler #1.
9. You do not maintain toilet facilities in good repair, to comply with 21 CFR 110.37(d)(2). Specifically, on May 4, 2016, our investigator observed cracks in the wall with vines hanging along the interior wall with a green moss looking substance throughout various areas in the restroom. Further wetness along the base of the west wall was observed.
10. You do not maintain toilet facilities in a sanitary condition for employees, to comply with 21 CFR 110.37(d)(1). Specifically, our investigator observed cigarette butts, wet tissue, and other debris scattered on the floor in the ladies restroom.
11. Your toilet facilities fail to have self-closing doors, to comply with 21 CFR 110.37 (d)(3). Specifically, on May 26, 2016, our investigator observed that the male and female restrooms lacked self-closing doors. We note that these restrooms are located approximately 20 feet from where fresh produce is prepared for delivery to customers.
12. You failed to store and dispose of rubbish to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces in accordance with 21 CFR 110.37(f). Specifically, throughout the inspection our investigator smelled an apparent fetid odor of rot, in unrefrigerated produce cooler #3. You informed our investigator that this is where spoiled products and trash are stored, until taken to the dumpster located outside your facility. For example, a container of spoiled onions, cardboard boxes, and other foreign matter was observed scattered on the floor in the cooler. Further, you informed our investigator that produce cooler #3 has not been cleaned in years.
13. Your employees failed to confine the use of tobacco to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(8). Specifically, on May 5, 2016, our investigator observed an employee smoking a cigarette and grabbing onions with his bare hand from an unmarked box, to fulfill an order for a customer.
14. You failed to provide, where necessary, protection against pests, as required by 21 CFR 110.20(b)(7). Specifically:
a. Loading door #1, located at the NE entrance of the facility, was observed to have a van pushed against the door causing a floor gap along the entire length of the door, up to 1 inch wide at the west side of the door.
b. Loading door #2, located directly west of door #1, serving as the main entrance to the firm, was observed to remain open throughout the inspection.
c. Loading door #4, located directly west of door #3, was observed to have two floor gaps at each side, approximately 4 inches high and over 12 inches long each.
d. Loading door #5, located directly west of door #4, was observed to have gaps on the east and west parts of the door approximately 1 inch to 3 inches wide and over 1.5 feet long, at the bottom of the door.
(b)(4)
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
(b)(4)
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You should take prompt action to correct the violations described above and prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
Further, Section 743 of the Act, 21 U.S.C. § 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 noncompliance 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 U.S.C. § 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 noncompliance 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 from your receipt of this letter, of the specific things that you are doing to correct the violations described above. As stated above, your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, 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.
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address on this letterhead. If you have any questions about this letter, please contact Ms. Bonner at 215-717-3074 or email her at Lynn.Bonner@fda.hhs.gov.
Sincerely,
/S/
Anne E. Johnson
District Director
Philadelphia District
cc:
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408
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