The FDA recently sent warning letters to officials with a seafood processing plant in Brooklyn, NY, and a company in Puerto Rico that makes seasoning mixes for shipment to the U.S. mainland.

Both companies are on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act. The agency sent the warning letters in August and September, making them public in recent days.

Companies are given 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.

Vinill Inc. — Brooklyn, NY
Inspectors found serious violations at the Vinill Inc. seafood processing and distribution operation when they were at the facility on Aug. 29 and Sept. 4, according to the FDA warning letter sent to owner Leonid Kats. The letter, dated Sept. 21, says the company’s efforts to bring the operation into compliance were insufficient.

The warning says failure by Vinill Inc. to comply means Clostridium botulinum growth and toxin formation is reasonably likely to occur. The toxin causes botulism, which is sometimes fatal. It frequently requires patients to be placed on ventilators because breathing muscles become paralyzed, as do other muscles in the body.   

“We acknowledge receipt of your electronic response email dated Sept. 6, 2018, responding to the Form FDA-483, Inspection Observations (FDA-483), issued to you on Sept. 4, 2018,” the letter states.

“… your response is inadequate because you did not provide any information that indicates you have conducted a hazard analysis and implemented an adequate (hazard control plan) for your refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish.”

Federal law requires food businesses to conduct Hazard Analysis and Critical Control Point (HACCP) reviews to asses food safety hazards that are reasonably likely to occur. Companies must also have and implement a written HACCP plan to control such hazards. 

Companies that are subject to the HACCP regulations must complete the HACCP process for each kind of fish or fishery product they handle. 

“once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list the hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply,” the warning states.

Don Julio Tropical Food LLC, Ponce, Puerto Rico
FDA officials sent a warning letter to company president Ernesto Vázquez Borrero citing repeat violations including dead roaches “too numerous to count;” filthy, dilapidated equipment, buildings and grounds; improper and infective cleaning and sanitizing of utensils; and ingredients being stored in filthy, uncovered containers.

Inspectors were at the Don Julio Tropical Food manufacturing facility on May 21 through June 1. They found seasoning mixes, raw garlic and other food products were prepared, packed, or held under insanitary conditions wherby they may have become contaminated with filth, or may have been rendered injurious to health.

The FDA warning listed the following violations:

1. You failed to take effective measures to exclude pests from the processing areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on 05/21/2018 and 05/22/2018 our investigator observed dead roaches’ parts too numerous to count in your firm’s warehouse floor next to ambient temperature raw materials such as sodium benzoate, dry onions, garlic granules, and oregano. You were previously cited for the same or similar violation during the 2009 and 2015 inspections.

2. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute to contamination from any source, as required by 21 CFR 110.80. Specifically, during the inspection our investigator observed while manufacturing various products with Lot No. 9450, such as “Sofrito Excelencia” (Condiment Mix) and “Ajo Puro” (Raw Grounded Garlic) the following:

• Employees in the manufacturing area wher re-using disposable items as utensils. These were at least five (5) empty plastic bleach containers that were cut in halves and were being re-used as scoops and funnels for collecting and/or dispensing ingredients, processing water, and finished products filling step.
• Air extractor screen in the production area was filthy and dusty, potentially allowing the falling of dust and dirt into in-process products and uncovered raw ingredients.
• A pair of rubber gloves used for cleaning purposes were hanging right above exposed “Ajo Puro” (Raw Grounded Garlic) finished product. Repeat observation from our 2009, 2012, and 2015 inspections.

3. You must store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(1). Specifically, on 05/21/2018 and 05/22/2018, our investigator observed:

• Ingredients such as dry onions, garlic, oregano, citric acid, and sodium benzoate stored in the ambient temperature area on top of soiled and dirty pallets. Additionally, the area was observed dusty, which could potentially contaminate ingredients.
• Ingredients such as red peppers and green peppers stored in the refrigerator area on pallets against the foam type walls. These foam type walls had missing sections and were soiled with what appears to be mold. In addition, the foam type ceiling was missing sections and soiled with what appears to be mold.
• Packaging cardboard boxes were stored inside your non-functional and dirty refrigerator and it had soiled walls and damaged ceiling areas.
• Preservatives ingredients such as salt, sodium benzoate, and citric acid placed in your manufacturing area were not properly labeled. In addition, these ingredients were stored in filthy containers and were kept un-covered while not in use. Repeat observation from our 2010 and 2015 inspections.

4. You failed to properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant building that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). Specifically, our investigator observed your firm’s warehouse area, wher packaging plastic bowls, plastic lids, and glass jar containers were stored, was also used to store waste material, had at least forty (40) not-in-use refrigerators, one (1) not-in-use forklift, one (1) not-in-use 300 gallons’ stainless steel tank, and old carton boxes. In addition, our investigator observed that an approximately 100 square feet area of the ceiling panels installed in your firm’s warehouse were detached from the ceiling leaving openings that provide a potential breeding place for pests. Repeat observation from our 2009, 2012, and 2015 inspections.

5. The procedures used for cleaning and sanitizing of utensils must provide adequate cleaning and sanitizing treatment as required by 21 CFR 110.35(d)(5). Specifically,

• The three (3)-compartment sink used to wash and sanitize glass jars re-used from returned products was not set up in the correct sequence of wash-rinse-sanitize. In addition, your firm manufacturing cleaning area does not have a three (3)-compartment sink and utensils are not properly cleaned while manufacturing is in progress.
• On 05/21/2018 and 05/22/2018, our investigator observed that plastic utensils were kept inside this single compartment sink and were being cleaned with water and soap alone. Repeat observation from our 2015 inspection.

6. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7).  Specifically, our investigator observed windows in processing area did not have any type of screening and doors leading to the receiving and/or dispatching of raw materials and finished products have a gap of approximately four (4) inches wide at the bottom. A second door connecting the exterior of the firm with this warehouse had a gap of approximately two (2) inches wide at the bottom. Repeat observation from our 2009 and 2015 inspections.

7. You failed to maintain buildings, fixtures or other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). Specifically, our investigator observed that the floors in your processing area are not constructed from a material that could be easily cleaned and kept clean. Gaps in between floor tiles had accumulated dirt and black stains that appeared to be mold. In addition, walls in the processing area had sections of missing tiles and showed presence of what appeared to be mold. During the inspection, your firm was formulating “Sofrito” (Condiment Mix) and “Ajo” (Raw Grounded Garlic) finished products. (Repeat observation from our 2009, 2010, and 2015 inspections).

The FDA warning letter noted that the company has not provided a written response to the Form FDA 483, Investigator Observations, issued to it on June 1. 

Also, the facility is not current with regulations requiring biennial registration renewal, which mandate submission of a renewal registration during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year. FDA records indicate that, as of the date of the warning letter, the facility had not been re-registered.

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