As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Porfirios Italian Foods Inc.
Trenton, NJ
A food firm in New Jersey is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
In a June 21, 2023, warning letter, the FDA described a Jan. 13 and 17 and March 17 inspection of Porfirios Italian Foods Inc.’s pasta manufacturing facility in Trenton, NJ.
The FDA determined that the pasta products manufactured in the facility are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility.
Some of the firm’s significant deviation is as follows:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm did not prepare, or have prepared and implement a food safety plan, as required. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). The firm’s food safety plan must also include the following:
1) The written hazard analysis
2) The written preventive controls
3) The written supply-chain program
4) The written recall plan
5) The written procedures for monitoring the implementation of the preventive controls
6) The written corrective action procedures
7) The written verification procedures
However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:
a) The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures pasta products containing allergens such as wheat, milk, and egg. The facility also manufactures a seafood pasta product – ravioli containing the lobster allergen. Additionally, they use shared equipment (i.e., (redacted) and (redacted) filler, and pasta sheeter) and utensils to manufacture pasta products containing different allergen profiles. Therefore, allergens are a known or reasonably foreseeable hazard. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling and use, and for labeling to ensure that all food allergens required to be stated are included on the label.
The firm does not have appropriate controls in place for the allergen cross-contact hazard. Their sanitation of the (redacted) mixer and (redacted) filler consists of scraping manually, blowing with compressed air, and wiping with a bleach sanitizing solution. This sanitation practice does not include cleaning with detergent between pasta products containing different allergenic ingredients. For example, they manufacture cheese ravioli, which does not contain seafood such as lobster, on the same (redacted) and (redacted) filler used to manufacture lobster ravioli without cleaning with detergent between products.
b) The firm did not identify and evaluate metal as a known or reasonably foreseeable hazard to determine whether it requires a preventive control. Metal screening in the bottom of wooden-framed sifters was observed to be broken and was missing metal pieces. They do not have metal detectors and are not implementing any other programs, such as visual inspection, to control the metal hazard.
c) The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures pasta products containing wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON).
The full warning letter can be viewed here.
STC India Private Limited
Mumbai, India
A food firm in India is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
In a July 21, 2023, warning letter, the FDA described a Jan. 12-17 inspection of STC India Private Limited’s food manufacturing facility in Mumbai, India.
The FDA determined that the ready-to-eat (RTE) mouth fresheners (mukhwas) manufactured in the firm’s facility are adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health.
At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing the deviations found at their facility.
Some of the firm’s significant deviation is as follows:
Hazard Analysis and Risk-Based Preventive Controls:
1. The firm’s hazard analysis for their RTE mukhwas products dated May 10, 2022, did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether the hazard requires a preventive control, as required. Specifically, their hazard analysis indicated “(redacted)” for biological hazards at the (redacted) step. However, the facility manufactures various mukhwas products which contain ingredients including seeds such as fennel, flax, coriander, watermelon, sesame, and pumpkin, and spices such as cumin, coriander, and black pepper, which have been associated with the hazard of Salmonella. Therefore, the pathogen of Salmonella is a known or reasonably foreseeable hazard. The hazard may be controlled during processing or at suppliers.
The firm’s Feb. 2 response included a revised Food Safety Plan and Preventive Control Plan dated Jan. 19, 2023. However, their revised hazard analysis did not identify bacterial pathogens, such as Salmonella, in ingredients such as seeds and spices as requiring a preventive control. It also does not appear that a (redacted) step has been identified. Their revised food safety plan indicates that “(redacted)”, which appears to indicate this is not a (redacted) step. Further, they did not identify any process or supply-chain preventive controls to address the hazard of Salmonella in these ingredients.
Current Good Manufacturing Practice
2. The firm did not take effective measures to exclude pests from their processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required. Specifically, rodent activity was observed throughout their facility as follows:
- On Jan. 12 the investigator observed apparent rodent excreta pellets in storage rooms where raw materials, including fennel seeds, awla, shredded coconut, and various semi-finished mukhwas, were stored and on the terrace where additional raw materials including fennel seeds, sesame seeds, amaranth seeds, pumpkin seeds and awla were stored. Specifically, the investigator observed:
o at least (redacted) apparent rodent excreta pellets on bags of fennel seeds (coated and uncoated) stored on the shelf close to the wall in the storage rooms on the (redacted) side, and extensive spillage of semi-finished product and raw materials (including Rajwadi mukhwas, Orange mukhwas, and Softy Takada) on the shelf and on the floor
o at least (redacted) apparent rodent excreta pellets on the floor close to the wall where they stored white plastic containers and blue drums in each storage room on the (redacted) sides.
o jute bags containing Awla chura (Indian gooseberry powder) stored on the east side storage area with holes exposing the product; apparent rodent excreta pellets were found approximately (redacted) feet from the bags
o a glue pad placed on the floor for pest control in the (redacted) room storage room on the (redacted) side (second floor), extensively laden with numerous apparent rodent excreta pellets and sprinkled over with raw materials and semi-finished mukhwas
- On Jan. 17, 2023, the investigator observed at least four apparent rodent excreta pellets in the attic space where Fresh Mint Mukhwas are manufactured, along with spilled coconut in that area.
3. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated, as required. Specifically, the investigator observed conditions that may serve as an attractant to pests and may restrict inspection/cleaning activities including:
- bags and plastic drums containing raw and in-process materials including sesame seeds, amaranth, and pumpkin seeds touching the wall in the storage area of the second floor and terrace
- clutter of plastic drums, plastic containers, and bags containing raw and in-process materials on the (redacted) side of the terrace
- clutter of boxes, empty woven polystyrene bags, plastic bags, and other materials on the (redacted) side of the (redacted) roaster
- dried food residue on dirty equipment including cover of the hopper where finished muskhas are processed, ribbon blender, and fill and seal machine
- extensive food residues in the bucket elevator, near the floor
The full warning letter can be viewed here.
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