A Ready-to-Eat (RTE) single-serve condiment manufacturer from New York and a shelf-stable RTE hot sauce manufacturer are both on notice from the Food and Drug Administration for violations of federal food safety rules.
The FDA sent warning letters to the companies in September and August of 2018 and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
Elwood International Inc., Copiague, NY
In a Sept. 27, 2018, warning letter to Founder, Owner and Chief Executive Officer Mr. Stuart Roll, and Vice-President Mr. Richard F. Roll, staff from the FDA discussed the inspection of the firm’s Copiague, NY warehouse facility, which revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC Rule) and the low-acid canned food regulations (LACF regulations).
“We determined that your food products are adulterated, in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” according to the warning letter.
The FDA investigator noted the following violations:
- During the inspection, the FDA collected a sample of the firm’s Elwood’s Fat-Free Low Sodium Ranch Dressing Artificial Flavor and found that it is a low-acid food product; “The inspection revealed serious violations of the LACF regulations.”
The FDA also acknowledged the firm’s voluntary recall of all lots of this product within expiry.
- The 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; “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.”
- The firm failed to exclude pests from their food plant to protect against contamination of food;
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 product.
- 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.
A physical sample was collected from the Production Room/Kitchen, Production Office, and Electrical Closet Areas during the inspection of the facility and was analyzed by the FDA’s laboratory; “The analysis of this sample confirmed the material collected consisted of rodent excreta pellets. The analytical results for this sample confirmed the presence of rodent activity within your facility.”
On 01/08/2018 at 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 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.
According to the warning letter, “the 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.”
At the 3 N Oak Street Facility
- A. On 01/08/2018 condensation from the ceiling and ceiling pipes was observed dripping throughout the 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, the 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 were observed on at least 11 boxes of a pallet of a 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 the 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.
The firm also failed to take effective measures to protect against the inclusion of metal or other extraneous material in food; “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.”
The firm also failed to maintain buildings, fixtures, and other physical facilities of their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated.
The plant did not have adequate sanitary facilities and accommodation for trash disposal; “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.”
The firm 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;
- 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, an 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 wastewater. 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.
The FDA reminded the firm of their responsibility for ensuring that their facility operates in compliance with the Act, the LACF regulations, the CGMP & PC rule, and other applicable requirements.
In an Aug. 10 warning letter to Mr. Anthony M. Labua-Keiser, the FDA described violations observed during an April 30 – May 3, 2018, inspection at the company’s facility where they manufacture shelf-stable, ready-to-eat hot sauces, which are acidified food products.
Acidified food processors are required by federal law to comply with Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food, which includes taking effective measures to keep conditions sanitary.
Some of the significant violations cited were:
- The firm failed to provide the FDA, before packing any new product, information on the scheduled process from a qualified processing authority filed with FDA for their Thai Chile Hot Sauce and Hot Hot Sauce. There is no scheduled process on file for this product.
“As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level and source and date of the establishment of the process, for each acidified food in each container size,” according to the warning letter.
- The firm failed to mark their acidified product bottles with an identifying code permanently visible to the naked eye which specifies the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed.
Specifically, the 8-digit code on the firm’s acidified food containers do not include the establishment where the product was packed, the name of the product and the date the product was processed; “Each container or product must be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and the period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.”
The FDA reminded the firm that the violations cited in this warning letter are not intended to be an all-inclusive statement of violations that exist in connection with the firm’s products.
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