A seafood facility and an acidified food processor are on notice from the Food and Drug Administration for violations of the federal Food, Drug and Cosmetic Act.

The FDA warned both companies in June this year. The warning letters were just recently posted for public view. The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations.

Kaltec Food Packaging Inc.
In a June 8 warning letter to company owner Harriet L. Mascara, the FDA described violations observed during an inspection Feb. 12-March 1 at the company’s facility where they manufacture acidified food products. The Port Jervis, NY, commercial processing facility engages in the thermal processing of acidified foods, according to the warning letter. 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 FDA has no acidified scheduled process on file under the firm’s registration for products processed at their facility including Jersey Tomato Sauce Marinara, Sweet and Savory Black Bean Sauce, Southeast Asian Sweet Chili, Korean Gochujang, Veggie Bolognese, Chipotle Pizza Sauce, Caramel Pumpkin Butter, Roja (Red Sauce), Verde (Green Sauce) and Blanco (White Sauce);
  • The firm could not provide evidence that the scheduled processes for the acidified food product Jersey Tomato Sauce Marinara that they manufacture was established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods;
  • The firm failed to manufacture their acidified food products in accordance with the scheduled process, including: The July 21, 2015 process letter for Sweet and Savory Black Bean Sauce product provided by a process authority identified the product as an acidified food and listed a fill temperature but the firm’s batch record template used during production states a different temperature range, and The process letter also provides the ingredients and weights of each ingredient to be used but during processing the firm is using ingredients that differ from the ingredients listed in the process letter;
  • The firm lacks processing records to show they are monitoring the process letter critical factor of pH in order to comply with 21 CFR 114.100(b);
  • The firm’s operators are not under the supervision of a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, and critical factors in acidification, and who has satisfactorily completed the prescribed course of instruction;
  • The firm failed to maintain production records of examination of raw materials, packaging materials, finished products, and supplier’s guarantees or certificates to verify compliance with FDA regulations and guidelines or actions levels; and
  • The firm’s records are not maintained documenting examination of raw materials and packaging materials.

The FDA also noted that the firm sent multiple response letters, however, they failed to implement and document said revisions or include revised production records.

LNZRO Pizza Empire Inc.
In a June 11 warning letter to company president George R. Musak, the FDA reported serious violations of the current Seafood Hazard Analysis and Critical Control Point (HACCP) regulation. According to the warning letter, the firm’s ready-to-eat canned crab meat and battered/breaded haddock were prepared, packaged or held under unsanitary conditions.

A May 10-11 inspection in Syracuse, NY, showed that the company was cited for the following violations:

  • The firm failed to conduct, or have conducted for them, hazard analysis for each kind of fish or fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, as well as implementing a written HACCP plan to control any food safety hazards that are reasonably likely to occur; “However, your firm did not have a HACCP plan for refrigerated, ready-to-eat canned crab meat to control the food safety hazard of Clostridium botulinum toxin formation.”

The firm’s June 1, 2018 electronic response letter included a copy of their revised HACCP plan for pasteurized canned crabmeat, however, “their response is inadequate because their HACCP plan did not contain, at a minimum, adequate critical limits, monitoring procedures or corrective action procedures.”

  • The firm must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3); Specifically, the firm’s monitoring records at the CCP for their battered/breaded haddock were not reviewed for the last year.
The FDA acknowledged the firm’s response dated June 1, 2018 which states “The monitoring records will be maintained correctly as required,” However, the firm’s response is inadequate because they have not provided any evidence demonstrating that all monitoring records are receiving a weekly verification review by a HACCP trained individual in accordance with 21 CFR 123.10(c).
Additionally, the FDA noted that as a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, the firm is responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.
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