Joy Gourmet Foods LLC MARCS-CMS 618704 — February 11, 2022

WARNING LETTER

---

• Delivery Method: United Parcel Service
• Product: Food & Beverages

---

• Recipient: Mr. Amit C. Gandhi; President & Co-Owner; Joy Gourmet Foods LLC; 48-80 Maspeth Ave.; Maspeth, NY 11378-2110; United States

• Issuing Office: Office of Human and Animal Food Operations East Division 1; United States

---

WARNING LETTER
CMS # 618704

February 11, 2022

Mr. Satish Parmar, Sales Manager & Co-Owner

Dear Messrs. Gandhi and Parmar:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) acidified chutneys and pastes manufacturing facility located at 48-80 Maspeth Ave., Maspeth, NY 11378-2110 from July 19, 2021 to August 25, 2021. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). Failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). The inspection also revealed serious violations of the regulations for acidified foods [Title 21, Code of Federal Regulations, part 108, Emergency Permit Control (21 CFR part 108) and part 114, Acidified Foods (21 CFR part 114)].

Accordingly, we have determined that your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) 342(a)(4)], because they have been 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. You can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.

As a manufacturer of acidified food products, you are required to comply with the Act and the federal regulations relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control, 21 U.S.C. 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR part 114. Regulations specific to the processing of acidified food products are described in 21 CFR part 108 and 21 CFR part 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR part 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR part 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).

Based on samples, inspectional observations, and record review, your firm recalled the following products.

Product/Batch Code	Batch Code(s)	Reason for Recall	Recall Classification
Joy Coriander Chutney	07 28	FDA Analysis of Sample 1151434 revealed undeclared sulfites	Class I
Joy Tamarind Chutney	06 19	FDA Analysis of Sample 1151433 revealed undeclared sulfites	Class II
Joy Green Chilli Chutney	07 19	The inspection revealed that the product contained undeclared sulfites, FD&C Yellow # 5, and coconut	Class II
Joy Mint Chutney	07 02 08 02	The inspection revealed that the product contained undeclared coconut.	Class II

At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations, listing the deviations found at your facility.

Your facility has submitted correspondence related to the recall. However, no correspondence has been received in response to the inspectional observations on the FDA 483. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (Subpart C):

1. You did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a). Specifically,

a. You 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. Your facility receives, stores, and manufactures products that contain the allergen tree nuts (e.g., coconut and cashew). 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 your circumstances would identify allergens as hazards requiring a preventive control.

b. You 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. Your 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. You did not identify and evaluate bacterial pathogens, such as Salmonella and Clostridium botulinum (C. botulinum), as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your 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. You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures/processes chutneys with coconut flour and cashews. These ingredients have been associated with mycotoxins.

e. You did not identify and evaluate metal or glass as a known or reasonably foreseeable hazard to determine whether they require a preventive control. You manufacture chutneys and pastes using a grinder with metal-on-metal contact, and you package them in glass jars.

2. You did not identify and implement adequate preventive controls for your 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 your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, as required by 21 CFR 117.135(a)(1). 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 (see 21 CFR 117.135). 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 (see 21 CFR 117.140).

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 (see 21 CFR 117.135(c)(2)). You did not implement your procedure that states “Check every label [for] proper ingredients” as evidenced by your 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, you do not have any monitoring records to show that this procedure was being implemented.

In addition, your 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. You state that you clean your shared equipment in between products, but you 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 (see 21 CFR 117.135(c)(1)). Your Natural Tamarind Concentrate, Tamarind Chutney, Coriander Chutney, Mint Chutney, and Green Chilli Chutney contain sulfites, and your Coriander Chutney and Mint Chutney contain Yellow #5. You do not have controls in place to control chemical hazards due to misformulation or incorrect labeling of substances associated with food intolerance. Further, we note that your production records do not show all ingredients used and the amount added to each lot. In 2019, after your facility recalled all chutneys, pastes, and concentrates for not declaring an additive, you implemented a procedure to “Check every label [for] proper ingredients.” However, you 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 your failure to include certain ingredients on your labels. Specifically, FDA testing of Coriander Chutney and Tamarind Chutney samples collected at your facility on August 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. You did not establish and implement adequate written procedures, including the frequency with which they are to be performed, for monitoring the preventive controls, as required by 21 CFR 117.145(a). Specifically, regarding the hazard of bacterial pathogens such as Clostridium botulinum and other bacterial pathogens, you maintain scheduled processes for the RTE acidified chutney and paste products that you manufacture; however, you 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. You did not document the monitoring of preventive controls, as required by 21 CFR 117.145(c)(1). Your scheduled process for RTE acidified Coriander Chutney identifies a cook temperature of ≥ (b)(4)℉ to be held for ≥ (b)(4), and minimum pack hold time of ≥ (b)(4). However, your records for the months of May, June, and July 2021 do not include any monitoring of the holding times.

5. You did not establish and implement written procedures for the method and frequency of calibrating process monitoring instruments and verification instruments (or checking them for accuracy), as required by 21 CFR 117.165(b)(1). Specifically, regarding the hazard of vegetative pathogens for RTE acidified chutney and paste products, you did not establish and implement written process control verification procedures for the methods and frequencies of your pH meter and temperature monitoring device accuracy checks. Further, the temperature monitoring device accuracy checks you do conduct are not adequate. According to your “pH Meter [Calibration] Report,” where you also record your temperature monitoring device accuracy checks, these checks were not performed using (b)(4) water or against a calibrated master thermometer. Instead, you used hot water, with resulting temperature readings of 145℉.

Current Good Manufacturing Practice (Subpart B):

1. Your 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, as required by 21 CFR 117.20(b)(4). 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.

2. You 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, as required by 21 CFR 117.35(c). Specifically, apparent flies were observed inside the main processing room and on top of the cardboard used to cover the in-process coriander chutney.

Specific Requirements and Conditions for Exemption from or Compliance with an Emergency Permit (Subpart B)

1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled process from a qualified processing authority filed with FDA for your Coconut Chutney 8 fl.oz, Fresh Mint Chutney 8 oz./26 oz. and Ginger Garlic Paste 8 oz./26oz. as required by 21 CFR 108.25(c)(2), Specifically, there are no scheduled processes on file for these products. We acknowledge that your firm filed processes for Ginger Garlic Paste (24 oz.) and Fresh Mint Chutney (32 oz.); however, a scheduled process is required for each acidified food product in each container size.

As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).

Scheduled process information for acidified foods must be submitted on Form FDA 2541e a (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication "Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format'' available at: https://www.fda.gov/food/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf/establishment-registration-process-filing-acidified-and-low-acid-canned-foods-lacf-paper-submissions

2. You failed to maintain processing and production records showing adherence to the scheduled processes, including records of pH measurement and critical factors intended to ensure a safe product, as required by 21 CFR 114.100(b). Specifically,

a. You did not have any production records for the following batches of RTE finished products observed at your facility:

Product Name	Identification Code
Bhel Chutney	05.05 BEST BY 053022
Chat Chutney	05.19 BEST BY 053022 / 05.20 BEST BY 053022
Tamarind and Dates Chutney	05.19 BEST BY 093022 / 07.02 BEST BY 093022 07.19 BEST BY 073022 / 06.20 BEST BY 093022
Gol-Gappa Masala Concentrate	05.20 BEST BY 093022 / 01.25 BEST BY 012222
Tandoori Paste	07.02 BEST BY 093022
Garlic Paste	05.20 BEST BY 053022

b. Your production records do not contain sufficient additional information such as product code, date, and container size to permit a public health hazard evaluation of the processes applied to each batch produced. In that:

• Your firm manufactures multiple batches on multiple days, and then labels them all with the same identification code. Additionally, your firm uses some of its finished products as ingredients in making other products, and the associated identification codes are not being
recorded on the production record for the final finished product. For example, your firm uses the Ginger Paste and Garlic Paste finished products, with the addition of other ingredients to manufacture the Tandoori Paste, and the identification codes of the ginger and garlic pastes used are not recorded in your production records. This is true for other products which your firm manufactures, such as Fresh Mint Chutney (Mint Chutney + Coriander Chutney), Ginger Garlic Paste (Ginger Paste + Garlic Paste), Green Chilli Chutney (Coriander Chutney + other ingredients), Idlee-Dosa Chutney (Dates & Tamarind Chutney + other ingredients).

• Your production records do not include all dates of manufacture, in that, your firm manufactures multiple batches on multiple days but only one date is being recorded.

• Your production records include a bulk size amount, but no container size information.

3. You failed to maintain identifying initial distribution of finished products to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use, as required by 21 CFR 114.100(d). Specifically, you informed our investigators that you do not keep initial distribution records which contain the product lot numbers for any of your outgoing finished products.

4. You failed to mark each container with an identifying code specifying the product contained therein and date, as required by 21 CFR 114.80(b). Your current product coding system for your entire product line does not allow for positive identification of the product within each container or its date of manufacture. Specifically,

a. On July 19, 2021 an investigator observed Coriander Chutney finished products marked with code “07.19 BEST BY 073022,” and you explained that (b)(4) it was packed. However, this code does not specify the product contained therein, and the actual packing date.

b. Your firm manufactures multiple batches on multiple days, and then labels them all with the same identification code. For example, your production records titled “May 2021” and “June July 2021” indicate that your firm manufactured Tamarind Chutney products during the weeks of (b)(4) and (b)(4); and all batches combined therein were marked with code “06.19 Best By 093022.” You explained that all finished products manufactured and packed within the week are considered as a single lot, and that all products within this lot are marked with the same identification code. This code is not changed often enough to enable ready identification of lots during sale and distribution.

Misbranding

1. Your products Bhel Chutney, Chat Chutney, Dates Chutney, Tamarind and Dates Chutney, Ginger Paste, and Ginger Garlic Paste are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that their product labels fail to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.4. Specifically,

a. During the inspection, your management stated that Bhel Chutney, Chat Chutney, Dates Chutney, and Tamarind and Dates Chutney are all made from the same formulation. However, their labels bear three different ingredient statements, and none of the ingredient statements list the same ingredients as the ingredients listed in the formulation you provided. For example, the formulation includes (b)(4) and (b)(4), which are not declared on any of the product labels.
b. The Ginger Paste label’s ingredient statement does not match the ingredients listed in the formulation you provided. For example, it fails to include ginger in the ingredient statement.
c. The Ginger Garlic Paste label’s ingredient statement does not match the ingredients listed in the formulation you provided. For example, the label lists “oil,” guar, tragacanth, xantha, and citric acid, which are not listed in the formulation and fails to list (b)(4), which is listed in the formulation. In addition, the ingredient list on the label does not specify the type of oil used.
d. The Dates Chutney label lists “jaggery,” which is not the common or usual name of a food ingredient.
e. Your Bhel Chutney, Tamarind and Dates Chutney, Ginger Paste, and Ginger Garlic Paste labels list “stabilizers” in the ingredient statement. There is no provision in the regulation for using the generic term “stabilizers.” Further, “stabilizer” is not part of the common or usual name of an ingredient and is intervening material within the ingredient statement.
f. The revised label for Mint Chutney (8 oz) fails to list preservatives in accordance with 21 CFR 101.4 and 21 CFR 101.22. Each ingredient must be declared by common or usual name in descending order of predominance within the ingredient list unless an exemption is provided in 21 CFR 101.100 or a collective (generic) name is provided in 21 CFR 101.4(b). The collective listing of preservatives is not provided for in 21 CFR 101.4(b). In accordance with 21 CFR 101.4 and 101.22, each preservative must be declared in descending order of predominance by both the common or usual name of the ingredient(s) and a separate description of its function. However, the revised Mint Chutney (8 oz) label lists the preservatives collectively in the ingredient statement, i.e., “sodium benzoate and sodium meta bi sulfite (for freshness).” These ingredients, and their preservative function, must be listed separately in the ingredient statement.
g. The formulations for the Tamarind Concentrate, Garlic Paste, and Ginger Paste include (b)(4) as an ingredient; however, these labels do not list (b)(4) in the ingredient statement.

2. Your products Mint Chutney, Bhel Chutney, Chat Chutney, Dates Chutney, Tamarind and Dates Chutney, and Ginger Garlic Paste are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (i.e., Nutrition Facts label) does not comply with the requirements in 21 CFR 101.9. For example:

a. The Ginger Garlic Paste label lists 11 grams of sugar, which is a carbohydrate, but just 2 grams of carbohydrates.
b. The Dates Chutney label lists zero grams of added sugars even though the label lists the ingredient “jaggery,” which is a type of sugar (21 CFR 101.9(c)(6)(iii)).
c. The declared Serving size of 1 tsp. for the Bhel Chutney, Chat Chutney, Mint Chutney 26 oz, and Tamarind & Dates Chutneys is not based on the appropriate Reference Amount Customarily Consumed (RACC) in accordance with 21 CFR 101.12(b).

3. Your Dates Chutney, Tamarind Concentrate, Ginger Garlic Paste, Bhel Chutney, Chat Chutney, and Tamarind & Dates Chutney products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the product labels fail to list chemical preservative ingredients and/or their function in accordance with 21 CFR 101.22(j). In accordance with 21 CFR 101.22(j), a food to which a chemical preservative(s) is added shall, except when exempt pursuant to § 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative”, “to retard spoilage”, “a mold inhibitor”, “to help protect flavor” or “to promote color retention.” For example:

a. The Dates Chutney and Tamarind Concentrate product labels’ ingredient statements list sodium benzoate and sodium metabisulfite, but do not describe their function as preservatives.
b. The Ginger Garlic Paste label and the revised Green Chilli Chutney, Coriander Chutney, and Tamarind Chutney labels list sodium benzoate but fail to list the preservative function of the ingredient, as required by 21 CFR 101.22(j).
c. The formulations for the Tamarind and Dates Chutney, Bhel Chutney, Chat Chutney, and Dates Chutney list the preservative (b)(4) as an ingredient; however, it is not declared on the labels’ ingredient statements.

4. Your Natural Tamarind Concentrate product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading because it describes the food as “natural” despite the food containing synthetic ingredients. FDA considers the use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic…has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993]. The formulations and ingredient statement for this product indicate that sodium benzoate and sodium metabisulfite have been added to the food. Sodium benzoate and sodium metabisulfite do not occur naturally and are synthetically produced.

The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to do so may result in legal action by the FDA without further notice, including without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Further, each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties, as required by 21 CFR 117.4(b)(2). You did not establish and maintain documentation of this training for each individual, as required by 21 CFR 117.4(d).

As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Manufacturers must revise labels to meet the new requirements. We note that several of your labels fail to bear the updated format or fail to meet the requirements of the new format. Further, we question the carbohydrate value of one gram and fiber and sugar values of zero grams as listed for the Bhel Chutney, Chat Chutney, and Tamarind and Dates Chutney products, given that the primary ingredients in these products are sugar, dates, and tamarind. For more information on the new requirements, please see https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.

Please respond in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433 or via email at Lillian.aveta@fda.hhs.gov (preferred). If you have any questions about the content of this letter, please contact Ms. Aveta at 718-662-5576 or email at Lillian.aveta@fda.hhs.gov.

Sincerely,
/S/

Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1