- My Chai Inc.
- Issuing Office:
- Seattle District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
In reply refer to Warning Letter SEA 15-03
Rajesh K. Champatiray, President and Owner
1110 SE Centennial Street, Suite #6
Dear Mr. Champatiray:
Based on your failure to comply with 21 CFR Part 114, 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 U.S.C. § 342(a)(4)], in that 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.
As an acidified foods processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and mandatory requirements of 21 CFR Part 114.
Additionally, based on your failure to comply with 21 CFR Part 110, we have determined that your food products are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that 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 may find the Act and the regulations for Emergency Permit Control, Acidified Foods and Current Good Manufacturing Practices through links on FDA’s home page at www.fda.gov.
We received your written response, dated September 24, 2014, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations.
Acidified Foods Violations
1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, 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).
Specifically, your firm has failed to file a scheduled process with FDA for acidified chai tea products that your firm manufactures, including the following six varieties packed in 64 fluid ounce plastic containers: My Chai Super chai tea; My Chai Sweet Dragon chai tea; Mychai chai tea; My Chai original chai tea; myChai original Double chai tea; and mychai Double chai tea. These products were determined to either be acidified foods or reprocessed acidified foods by your process authority as evidenced by process source documentation obtained by our investigators during the inspection. Your firm has also failed to file a process for another acidified food that you manufacture, Oregon Orchards Banana smoothie concentrate.
Your written response dated September 24, 2014, is inadequate as no documentation was provided to demonstrate that scheduled processes were filed with FDA. We acknowledge that your firm had provided our investigators with completed copies of the Form FDA 2541a (Food Process Filing For All Methods Except Low-Acid Aseptic) for seven acidified chai tea products; however, FDA had only received forms for two products, My Chai Super (SID (b)(4)) and My Chai Sweet Dragon (SID (b)(4)), both of which were incomplete with insufficient information and were returned to you on January 27, 2014. When process filings are returned by FDA, they are not considered to have been filed with the FDA and therefore do not meet the requirements of 21 CFR 108.25(c)(2). We subsequently treat the products identified on these returned forms as not having complied with 21 CFR 108.25(c)(2) until we receive completed process filings. If you wish to manufacture these acidified food products, scheduled processes need to be resubmitted with the appropriate process information in order to be in compliance with 21 CFR 108.25(c)(2).
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Food Process Filing For All Methods Except Low-Acid Aseptic). Additional information on filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at: www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/ucm2007437.htm.
Plastic milk jugs or non-flexible plastic bottles were hot filled with acidified chai tea at approximately (b)(4)°F and then closed with caps without forming a vacuum. Electrical tape was then applied around caps for some customers to prevent leaking during shipment. Our investigators observed pallets of acidified chai tea products stacked up to four layers high, with paperboard slip sheets separating layers. Your firm had determined that containers leaked after hot fill, during subsequent storage or during distribution, and had routinely pulled leaking containers from inventory for re-processing.
Your written response dated September 24, 2014, is inadequate as it states that your issue with heat sealed caps has been resolved; however, your response does not indicate how your process was modified to prevent recurrence and ensure that container closures are suitable to protect food from leakage and contamination. Your response states that your process authority is assisting with leaking bottles; however, your response does not indicate interim controls for any leaking bottles found from your existing inventory or subsequent manufacturing. Your response does not include documentation completed by the operator performing the visual inspection demonstrating the results of non-destructive or destructive tests. Additionally, your response does not provide a timeframe for implementation of corrective actions.
3. Your firm failed to establish scheduled processes by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods, as required by 21 CFR 114.83. Specifically, no scheduled process was established for your Oregon Orchards Banana smoothie concentrate in 64 fluid ounce plastic containers.
Additionally, your batch records dated May 3, 2013, and July 23, 2013, for the Oregon Orchards Banana smoothie concentrate indicated the initial pH was above 4.6. Citric acid was added and the final or equilibrium pH was below 4.6. The preservative sodium benzoate was added to this product, and this product was not subjected to a thermal process. Your firm labels this product with a two year shelf life without a keep refrigerated statement. Our investigators observed (b)(4) units of this Oregon Orchards Banana smoothie concentrate, produced July 23, 2013, held in your “walk-in cooler” at 63 to 67°F on August 18, 19 and 20, 2014.
Acidified foods are low-acid foods to which acid or acid foods are added. These foods have a water activity greater than 0.85 and have a finished equilibrium pH of 4.6 or below, as defined in 21 CFR 114.3(b). You used fresh bananas and citric acid which reduced the pH of your product making the banana smoothie an acidified food.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of these products, including sugar-free syrups, are considered acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114, including process filing, for those products that are determined to be acidified foods.
Your written response dated September 24, 2014, stated that you are working with your processing authority to develop a process solution for smoothie concentrates and sugar-free syrups. As of the date of this letter, you have not provided scheduled processes to the FDA. Your response states that you are purchasing heat treated aseptic bananas instead of producing banana puree; however, this proposed corrective action is inadequate if the initial pH of bananas remains above 4.6. Your response is further inadequate because it does not describe whether interim controls are in place when scheduled processes have not been established, and your response does not provide a timeframe for implementation of corrective actions.
4. Your firm failed to store and transport finished food under conditions that would protect against physical contamination, as required by 21 CFR 110.93. Specifically our investigators observed finished syrup and chocolate products identified with an “X” on the container cap and wrapped with black electrical tape staged for distribution in your warehouse, including two containers of (b)(4) Hazelnut Syrup, at least ten containers of (b)(4) Mojito Cuban Syrup and four containers of (b)(4) Premium Chocolate Sauce. Your firm explained that “X” is written onto containers which exhibit signs of leaking.
Your written response dated September 24, 2014, is inadequate as it describes steps taken to quarantine leaky or defective product; however, your response does not include documentation demonstrating that these procedures have been implemented. Your response does not describe the disposition of these quarantined products. Your response also does not describe the disposition of affected product before your quarantine process went into effect, and your response does not describe corrective actions taken to address the process and prevent its recurrence.
5. Your firm failed to hold raw materials, rework materials and ingredients at proper temperatures and humidity to prevent the food from becoming adulterated, as required by 21 CFR 110.80(a)(5). Specifically, your office space which was converted into a “walk-in cooler” with an air conditioning unit and insulation was measured by our investigators at temperatures between 63 to 67°F from August 18 to 20, 2014, while your air conditioning wall unit indicated a setting of “60” and the digital display wired to the unit read “6864 F.” Our investigators found your “walk-in cooler” contained the following items: half and half dated July 30, 2014; chai teas stored in white (b)(4) plastic buckets for reprocessing; banana smoothie concentrate; and mango pulp stored in white (b)(4) plastic buckets, one of which demonstrated signs of bloating. Additionally, our investigators observed lids of mango pulp buckets were labeled “SB,” indicating that sodium benzoate was sprayed onto the mango pulp to prevent mold growth.
Your written response dated September 24, 2014, is inadequate as it describes that a data logger was installed and that the thermostat would be monitored daily; however, your response does not address the disposition of food items that had been stored within the walk-in cooler or the disposition of product made with these food items. Your written response also does not address whether a set temperature has been established for the “walk-in cooler” and whether temperatures are maintained to ensure food safety. It is not apparent that your air conditioning unit is adequate to achieve appropriate refrigeration capacity.
6. Your firm failed to maintain buildings, fixtures and other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). Specifically our investigators observed:
a. Brown powder dusted on the surface of the ingredients maltodextrin, in (b)(4) pound paper bags, and nonfat dry milk, in (b)(4) pound paper bags, stored on pallets along the East wall of the warehouse and adjacent to the ribbon mixer.
c. Spider webbing and dust along warehouse walls as well as spider webbing with insects in the North window and covering rodent snap traps on the North wall.
d. Cluttered storage of items not used for production, near the clean utensil storage racks and in the warehouse, which may become pest harborage areas.
e. Residues from various spilled products on paperboard slip sheets under containers of finished product.
f. Spilled products, including chai tea and chocolate sauce, on the wall and floor under and around finished product storage pallets along the East wall in the warehouse.
g. Used and soiled employee outer garments and soiled cloth towels piled in a large mound within six feet of both the clean outer garment storage bins and clean utensil storage rack.
Your written response dated September 24, 2014, stated that you have rectified all of the observations, rented additional storage space and expanded the production floor. Your response is inadequate as it does not provide documentation that corrective actions were made and does not indicate how your firm would prevent future recurrence of sanitation deficiencies.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the acidified foods regulation (21 CFR Parts 108 and 114) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product, enjoin your firm from operating, and/or issue an Order of Need to obtain and hold a Temporary Emergency Permit.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.