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. The FDA frequently redacts parts of warning letters posted for public view.
Joy Gourmet Foods LLC
Maspeth, NY
A food company in New York 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 Feb. 11, 2022, warning letter the FDA described a July 19 through Aug. 25, 2021, inspection of Joy Gourmet Foods LLC in Maspeth, NY.
The FDA’s inspection revealed that the firm was not in compliance with Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and that the firm’s acidified food products are adulterated within the meaning of Section 402 of the Federal Food, Drug, and Cosmetic Act.
These violations resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
- The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at its facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically:
a. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard that requires a preventive control. Their facility receives, stores, and manufactures products that contain the allergen tree nuts including coconut and cashews. Foods containing allergens can cause serious adverse health consequences or death to allergic individuals if they consume a food to which they are allergic. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as hazards requiring a preventive control.
b. The firm did not identify and evaluate chemical hazards due to misformulation or incorrect labeling of substances associated with food intolerance as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures chutney and paste products with sulfites and Yellow #5. These additives can be a chemical hazard if present in certain quantities and not declared on the label. People sensitive to sulfiting agents can experience symptoms that range from mild to life threatening reactions. In addition, people sensitive to Yellow #5 can experience symptoms that range from mild to moderately severe.
c. The firm did not identify and evaluate bacterial pathogens, such as Salmonella and Clostridium botulinum, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. The facility manufactures/processes acidified chutneys and pastes with dried tamarind and coconut flour. These ingredients have been associated with pathogens such as Salmonella and C. botulinum.
d. 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/processes chutneys with coconut flour and cashews. These ingredients have been associated with mycotoxins.
e. The firm did not identify and evaluate metal or glass as a known or reasonably foreseeable hazard to determine whether they require a preventive control. They manufacture chutneys and pastes using a grinder with metal-on-metal contact, and they package them in glass jars.
2. The firm did not identify and implement adequate preventive controls for its chutney and pastes to provide assurance 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 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.
a. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens are included on the label and that food is protected against allergen cross-contact. They did not implement their procedure that states “Check every label [for] proper ingredients” as evidenced by their recall of Mint Chutney and Green Chilli Chutney because the products contained the tree nut coconut, which was not declared on the product label as noted above. Further, they do not have any monitoring records to show that this procedure was being implemented.
In addition, the firm’s facility manufactures multiple products with different allergen profiles, including chutney products that contain tree nuts, e.g., cashew and coconut, and that do not contain tree nuts on the same day and on shared equipment, which can result in allergen cross-contact without appropriate controls. They state that they clean their shared equipment in between products, but they do not have any monitoring records that show that this cleaning is being performed.
b. Process controls include procedures, practices, and processes to ensure the control of parameters during operations. Their Natural Tamarind Concentrate, Tamarind Chutney, Coriander Chutney, Mint Chutney, and Green Chilli Chutney contain sulfites, and their Coriander Chutney and Mint Chutney contain Yellow #5. They do not have controls in place to control chemical hazards due to misformulation or incorrect labeling of substances associated with food intolerance. Further, the FDA notes that their production records do not show all ingredients used and the amount added to each lot. In 2019, after their facility recalled all chutneys, pastes, and concentrates for not declaring an additive, they implemented a procedure to “Check every label [for] proper ingredients.” However, they do not have any monitoring records to show that this procedure was being implemented. The need for a preventive control to address this hazard is illustrated by their failure to include certain ingredients on their labels. Specifically, FDA testing of Coriander Chutney and Tamarind Chutney samples collected at their facility on Aug. 9, 2021, showed that sulfites were added to these products and levels were above 10 ppm; however, sulfites were not declared on the product labels. The inspection also found that one lot of Green Chilli Chutney contained FD&C Yellow#5, which was not declared on the product label. As noted above, these products were subsequently recalled.
3. The firm did not establish and implement adequate written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls. Specifically, regarding the hazard of bacterial pathogens such as Clostridium botulinum and other bacterial pathogens, they maintain scheduled processes for the RTE acidified chutney and paste products that they manufacture; however, they do not have written procedures in place specifying the frequency at which process controls (pH and time/temperature for your thermal process) are to be performed.
4. The firm did not document the monitoring of preventive controls. Their scheduled process for RTE acidified Coriander Chutney identifies a cook temperature of ≥ (redacted)℉ to be held for ≥ (redacted), and minimum pack hold time of ≥ (redacted). However, their records for the months of May, June, and July 2021 do not include any monitoring of the holding times.
5. The firm did not establish and implement written procedures for the method and frequency of calibrating process monitoring instruments and verification instruments, specifically, regarding the hazard of vegetative pathogens for RTE acidified chutney and paste products, they did not establish and implement written process control verification procedures for the methods and frequencies of their pH meter and temperature monitoring device accuracy checks. Further, the temperature monitoring device accuracy checks they do conduct are not adequate.
Current Good Manufacturing Practice (Subpart B):
- The firm’s plant was 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. Specifically, water droplets were observed dripping on top of the cardboard box that was being used to cover bags of sodium benzoate and sodium metabisulfite.
- The firm did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. Specifically, apparent flies were observed inside the main processing room and on top of the cardboard used to cover the in-process coriander chutney.
The full warning letter can be viewed here.
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