Joy Gourmet Foods LLC
Maspeth, NY
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
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.
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.
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):
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