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WARNING LETTER

STC India Private Limited MARCS-CMS 661775 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Bhavya P. Shah
Recipient Title
Director
STC India Private Limited

#201, 2nd Floor, Jyoti Industrial Estate, Shakti Nagar, C.S. Road Dasihar-East
Mumbai 400068
Maharashtra
India

bhavyashah@chandanmukhwas.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States


July 21, 2023

WARNING LETTER

Reference # 661775

Dear Mr. Shah:

The United States (U.S.) Food and Drug Administration (FDA) inspected your food manufacturing facility, located at #201, 2nd Floor, Jyoti Industrial Estate, Shakti Nagar, C.S. Road, Dasihar-East, Mumbai, Maharastra-400068, India on January 12-17, 2023. The inspection covered your ready-to-eat (RTE) mouth fresheners (mukhwas). 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). At the conclusion of the inspection, FDA issued an FDA Form 483, Inspectional Observations (FDA Form 483), listing the deviations found at your facility.

Based on FDA’s inspectional findings, we have determined that the RTE mouth fresheners (mukhwas) manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Codes (U.S.C.) § 342(a)(4)] 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. In addition, 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)]. You may find the Act and further information about the CGMP & PC rule through links in FDA’s Internet home page at http://www.fda.gov.

We received your response to the Form FDA 483 emailed to us on February 2, 2023, which included a description of your corrective actions and supporting documents including photos, a revised food safety plan and procedures, monitoring records, and calibration records. We received your additional response on February 5, 2023 which included your revised product labels. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility. We also address your responses below.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. Your hazard analysis for your 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 by 21 CFR 117.130(a)(1). Specifically, your hazard analysis indicated “(b)(4)” for biological hazards at the (b)(4) step. However, your facility manufactures various mukhwas products which contain ingredients including seeds (e.g., fennel, flax, coriander, watermelon, sesame, and pumpkin) and spices (e.g., 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. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify pathogens as a hazard requiring a preventive control in these ingredients. The hazard may be controlled during your processing or at your suppliers.

You did not identify a process preventive control such as a lethal treatment to significantly minimize or prevent bacterial pathogens, such as Salmonella, associated with the ingredients in your RTE mukhwas products. Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing. Where appropriate, process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values, or combination of values, needed to significantly control the hazards (see 21 CFR 117.135(c)(1)). These controls must be validated (see 21 CFR 117.160).

You did not identify a supply-chain program to verify control of bacterial pathogens, such as Salmonella, in seed and spice ingredients before your receipt. A facility that identifies raw materials and other ingredients with hazards such as Salmonella that require a supply-chain-applied control must establish and implement a risk-based supply-chain program for those raw materials and ingredients (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). Salmonella in RTE ingredients is a hazard that can cause serious adverse health consequences or death. Therefore, an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled (see 21 CFR 117.430(b)). The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (see 21 CFR 117.430(b)(1)(ii)).

Your February 2 response included a revised Food Safety Plan and Preventive Control Plan dated January 19, 2023. However, your 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 (b)(4) step has been identified. Your revised food safety plan indicates that “(b)(4)”, which appears to indicate this is not a (b)(4) step. Further, you did not identify any process or supply-chain preventive controls to address the hazard of Salmonella in these ingredients.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

2. You did not take effective measures to exclude pests from your 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, rodent activity was observed throughout your facility as follows:

  • On January 12, 2023, 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 (b)(4) 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 (b)(4) 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 (b)(4) apparent rodent excreta pellets on the floor close to the wall where you stored white plastic containers and blue drums in each storage room on the (b)(4) 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 (b)(4) feet from the bags
    o a glue pad placed on the floor for pest control in the (b)(4) room storage room on the (b)(4) side (second floor), extensively laden with numerous apparent rodent excreta pellets and sprinkled over with raw materials and semi-finished mukhwas

  • On January 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.

We note that it is unclear from review of your service reports from your outside pest company as to what “(b)(4)” and what “(b)(4)” refers to due to illegible writing. Also, service reports from December 2022 and January 2023 were missing.

3. You did not maintain your plant in a clean and sanitary condition and keep your plant in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, the investigator observed conditions which 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 (b)(4) side of the terrace
  • clutter of boxes, empty woven polystyrene bags, plastic bags, and other materials on the (b)(4) side of the (b)(4) roaster
  • dried food residue on dirty equipment (e.g., 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

We reviewed the corrective actions and documentation submitted in your response dated February 2, 2023. It remains unclear what type of inspection service your firm utilizes for pests including rodents, ants, lizards, flies, and cockroaches. A visual inspection for pests does not appear sufficient. Appropriate traps placed and maintained continuously in specific areas should be inspected regularly for pest activity, and controls should be based on those findings. Also, the contract period with the outside pest company appears to have expired on June 24, 2023. It is unclear how pest control is addressed by your firm after that date.

Additionally, your February 2, 2023 response states the storage of product outside has stopped and that damaged and unwanted material was scrapped. However, the photos of corrections to the observations noted in the FDA Form 483 provided were limited and did not include all storage areas. Also, your response did not explain how storage areas will be organized to allow for proper cleaning on a long term basis. Further, photos provided were not labeled to indicate which location and or correction they pertain to.

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist 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. You should take prompt action to correct or implement corrections to the violations cited in this letter.

Failure to adequately address this matter may lead to regulatory action. For instance, we may take further action to refuse admission of your imported products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information regarding ready-to-eat human food products that appear to have been prepared, packed, or held under insanitary conditions is Import Alert #99-43. You may view this alert at: Import Alert 99-43 (fda.gov).

Additional Comments:

We also note that your revised food safety plan provided with your response on February 2, 2023 includes sanitation preventive controls and references environmental monitoring. Environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR § 117.165(a)(3)). Note that if environmental monitoring is required, an environmental monitoring written procedure must be established and implemented and must meet the requirements in 21 CFR § 117.165(b)(3).

We will verify the adequacy and ongoing implementation of your corrective actions during a future inspection.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response to this letter should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.

You should direct your written reply to Marco Esteves, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Mr. Esteves via email at Marco.Esteves@fda.hhs.gov. Please reference #661775 on any submissions and on the subject line of any emails to us.

Sincerely,
/S/

Amy Barringer,
Deputy Director
for Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

 
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