- Delivery Method:
- VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
- Food & Beverages
Recipient NameMr. Sourabh Roy
- Gold Coast Distributors Inc. dba Shah Distributors
2325 W. Charter Way
Stockton, CA 95206-1135
- Issuing Office:
- Division of Human and Animal Food Operations West V
Dear Mr. Roy:
The United States Food and Drug Administration (FDA) inspected your ambient and frozen warehouse and re-packing facility, located at 2325 W. Charter Way, Stockton, CA 95206, from May 09-27, 2022. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent, insect, or cat filth present all throughout your facility.
Based on inspectional and analytical findings, we determined the food products packaged and/or held in your facility 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 your products 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 further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov. Further, we have reviewed the Ghee product label that was collected during the inspection and found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your product to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343], as discussed below.
(b)(4). Further, we received your written response to the FDA-483, dated June 07, 2022, which described corrective actions taken by your firm and included photographs and pest control service reports. Based on our review of the inspectional finding and the response that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
1. You did not take effective measures to exclude pests from your 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, insect, and animal activity was observed throughout your facility including, but not limited to the following:
Rodent Activity observed:
Dry storage room at (b)(4) end of warehouse
- On May 9, 12, 16, and 17, 2022, numerous rodent excreta pellets (REPs) and several rodent gnawed cardboard co-mingled cases containing various food products (including spices) were observed on pallets and on the floor up against the north, east, and southwest sides of the room. REPs were on floor, on the ledges of the windows along the north wall, and on shelves in an adjacent room (where labels and equipment were stored) at the (b)(4) of the room.
- On May 9, 12, 16, and 17, 2022, two rodent gnawed cardboard cases, having rodent rub marks, REPs, and nesting material that each contained at least (b)(4)/2 oz. retail bags of (b)(4) paprika spice, were observed on the center pallet against the west wall. One dead rodent was observed in between one of the cases of paprika spice and another case of spice products. At least (b)(4) bags within each case were rodent gnawed where paprika spilled out and onto other bags within the box. REPs, rodent hairs, and rodent nesting material were observed in each box and on, around, and inside (b)(4) of paprika.
- On May 9, 12, 16, and 17, 2022, one rodent gnawed cardboard case having REPs and rodent rub marks contained at least (b)(4)/4 oz. retail bags of (b)(4) Cumin Seeds. Inside of the box there were at least 2 rodent gnawed bags, and at least 50 REPs, rodent nesting material, and a dead and decayed rodent all nestled within the bags of cumin seeds. The box was located on a pallet at the southwest corner of the room.
- On May 9, 12, 16, and 17, 2022, one cardboard case was observed to contain 10 packs of 6/50g boxes of Shan Seasoning Mix Fish Biryani (mix for Spicy Fish Pilaf). At least 5 boxes had rodent gnaw marks. At least 40 REPs were on and in between boxes of the seasoning. All boxes had rodent rub marks and rodent urine stains that made the labeling of the products mostly illegible. The case was located on a pallet against the west wall of the room.
- On May 9, 12, 16, and 17, 2022, at least 2 rodent gnawed holes, rodent rub marks, and at least 30 REPs were observed on 1 cardboard case containing at least (b)(4)/24 oz. bags of (b)(4) brand Wheat Pelted (Whole). Within the case, there were at least 5 bags that had rodent gnaw marks where wheat pellet product had spilled out and onto other bags. REPs and rodent nesting material were in the case and inside the rodent gnawed bags. This case was located on boxes along the southwest corner of the room.
- On May 9, 12, 16, and 17, 2022, one rodent gnawed cardboard case was observed to contain at least (b)(4)/4 oz. retail bags of (b)(4) Granulated Garlic. Within the box there were at least 2 bags that had rodent gnawed holes along with at least 15 REPs on and in between bags. The case was located on the pallet at the southwest wall of the room.
- On May 9, 12, 16, and 17, 2022, one cardboard case located on the floor (along with other cases of food products) at the south wall contained at least 5 rodent gnawed bags of (b)(4) tea sweetener and at least 9 rodent gnawed boxes labeled (b)(4) brand. REPs and rodent nesting material were inside every bag, as well as on and in between every box. Rodent rub marks and rodent urine stains on the boxes made the labeling of most boxes illegible.
- On May 9, 12, 16, and 17, 2022, one cardboard case was observed with at least three apparent rodent gnaw marks containing approximately (b)(4)/6 pack shrink wrapped packages of (b)(4) boxes of Shah brand Punjabi Yakhni Pilau. Within this case, there were at least five boxes that had apparent rodent gnaw marks. And at least 20 REPs and apparent rodent urine staining were observed on at least 16 boxes. The case was located along the south wall of the room.
- On May 9, 12, 16-19, and 23, 2022, a large hole (approximately 2’ x 4”) surrounded by sagging sheet rock with black and brown stains was observed in the ceiling above pallets of packaged food product and paper records at the east end of the room. At least 50 REPs, rodent nesting material (including wads of pink insulation) and apparent rodent hairs were on and within 3 opened boxes of paper records below this hole.
- On May 19, 2022, after all food products were removed from the storage room, hundreds of REPs, spilled spice products, fragments of rodent gnawed food packing, and rodent nesting material were on the floor of the room. One dead rodent was on the floor at the north wall near the entrance to the room. Two holes, each 3” x 3” and each containing REPs and rodent nesting material, were observed in the south and west walls. These holes were not observed previously during the inspection due to pallets of boxes of spice products stored next to each other and up against walls.
Southwest side of the warehouse
- On May 9, 12, 16-19, and 23, 2022, at least 200 apparent REPs were observed on a box of incense sticks on the top layer of a pallet containing (b)(4) boxes. At least 10 REPs were found on a box of the (b)(4) layer of this pallet. The pallet was located at the north end of the warehouse and immediately adjacent to pallets of spice products, including Shan brand Fish Marsala.
Northwest side of the warehouse
- On May 23, 2022, three apparent REPs were observed on 40 lb. bags of (b)(4) brand basmati sela rice on a pallet containing (b)(4) bags. One bag on this pallet had an apparent rodent gnawed hole approximately 3” x 3” that was surrounded by yellowish stains.
Inside (b)(4) freezer at the northwest end of warehouse
- On May 17, 2022, an apparent rodent urine stain, approximately 1/2” x 2”, was observed on the floor below returned food products along the southwest wall. Within the (b)(4) freezer, pallets of boxes of food products were stored up against walls and immediately adjacent to each other within the aisles of the pallet racks. There were no aisles in between the pallets and the racks, making the center and the entire north wall inaccessible for a visual inspection.
Southeast end of the warehouse
- On May 9, 12, 16-19, and 23, 2022, one dead rodent was found in tin cat #23 located at the entrance to the warehouse from the administrative offices at the southeast side.
Insect activity observed:
- On May 12, 2022, live and dead insects in winged, crawling and larvae forms as well as moth webbing were observed on every bag of every layer of (b)(4) pallets each containing (b)(4)/55 lb. bags of (b)(4) (split chickpeas). Insect bored holes were observed in at least 4 bags of each pallet. (b)(4) product below the bored holes appeared clumped with insect eggs and had crawling insects. These pallets were located on the (b)(4) of pallet (b)(4) in the warehouse.
- On May 9, 12, 16-19, and 23, 2022, live and dead insects in winged, crawling and larvae forms were observed on and inside several opened bags of products including cashews, cumin spice, curry spice, fennel, bay leaves, legumes, and cinnamon that were in a pile with other food products on the floor of the repack room located at the south end of the warehouse.
- On May 23, 2022, an opened, unlabeled cardboard case (3’ x 3’) containing yellow legumes had live and dead insects on the legumes and on the plastic wrap that lightly covered the box. This box was located near the entrance to the repack room at the south end of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, live and dead insects in flying, crawling, and larvae forms were observed on and in between bags of expired Swarna brand whole wheat flour that were on (b)(4) pallets each containing at least (b)(4)/20 lb. bags. Live and dead flying and crawling insects were observed on and in between the bags and shrink wrap of all (b)(4) pallets. Two opened bags contained at least 6 winged and crawling insects. The (b)(4) pallets were located next to pallets of boxes and bags of food product including basmati rice at the north end of the warehouse.
- On May 23, 2022, at least 5 dead insects were observed around a 1” x 1” hole in a 25 lb. bag of expired (b)(4) brand desiccated coconut. The bag was on a pallet of (b)(4)/25 lb. soiled and dirty bags located between roll up doors 2 and 3 at the east end of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, pallets of boxes of food products (including soup mixes and (b)(4) brand drinks) returned from a customer that were observed damaged, dirty, and showing insect activity were commingled with food products intended for sale along the east and west sides of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, dead and/or live cockroaches were found in 18 tin cats staged round the inside perimeter of the warehouse. These included 34 live and dead cockroaches in tin cat #4 located between roll up doors 2 and 3 along the east wall; 30 live and dead cockroaches in tin cat #10 at the north wall; 70 live and dead cockroaches in tin cat# 14 at the west wall; and 49 live and dead cockroaches in tin cat #17 at the southwest wall.
- On May 16, 2022, live and dead insects in winged, crawling and larvae forms were found on and around boxes and bags of various food products (including basmati rice) located at each pallet rack within the center of the warehouse.
Animal activity observed:
- On May 9, 12, 16-19, and 23, 2022, piles of cat feces were observed on the floor at the north wall, northeast corner, south wall, southeast corner, west wall, and northwest corner of the warehouse. A pile of cat feces was also observed under pallet (b)(4) beneath boxes of soft drink beverage products.
- On May 17, 2022, at least 4 empty bags of dried cat food were observed in the room above the repack room. Animal paw prints were observed on dusty boxes (holding food products such as (b)(4) instant mix) located at the north, south, and southwest ends of the warehouse. Animal paw prints were observed on boxes of (b)(4) brand cookies located on a pallet near the entrance to the dry storage room.
- On May 12, 2022, cat urine was identified on 2/55 lb. bags of (b)(4) (split chickpeas) that were located on layers (b)(4) pallet containing (b)(4)/55 lb. bags. This pallet was located on the (b)(4) of pallet (b)(4). A bag of (b)(4) product on the top layer was found saturated with cat urine.
- On May 18, 2022, at approximately 11:00 AM, one live apparent bat was observed flying in circles and landing in the seam between two concrete slabs and a wooden ceiling joist along the south wall between the dry goods storage room and the west wall of the warehouse.
Structural deficiencies observed:
- On May 9, 12, 16-19, and 23, 2022, a gap approximately 2’ x 4” was observed at the upper right side of the closed rollup door #1 at the east end of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, a hole approximately 3” x 3” was observed at the left side and base of closed roll up door #2 at the east end of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, a gap approximately 2” x 1” was observed at the center and base of closed roll up door #3 at the east end of the warehouse.
- On May 9, 12, 16-19, and 23, 2022, a pedestrian door #10, located at the northeast end of the warehouse, was ajar and held closed with a belt. There was a 1”- 3” gap that spanned the base of the door, and a 1 ½’ x 3” gap along the lower right side of the door.
- On May 9, 12, 16-19, and 23, 2022, a gap approximately 1” to 3” was observed at the base of the closed pedestrian door, located at tin cat #12 at the northwest end of the warehouse.
Harborage areas inside the warehouse observed:
- On May 9, 12, 16-19, and 23, 2022, pallets of boxes of Shan brand food products (including pickles and spices) were stored immediately adjacent to each other and up against walls all along the north wall of the warehouse. Tin cats # 6, 8, and 9 placed by the pest control provider along the north wall were either missing or inaccessible.
- On May 9, 12, 16-19, and 23, 2022, pallets of boxes of food products returned from customers that were damaged, dirty, and showing insect or rodent activity were commingled with products slated for sale to customers along the east and west sides of the warehouse.
Pest control records:
In addition to visual observations, our investigators conducted a review of your third-party pest control provider inspection reports which revealed the following:
- Report dated 11/20/2019 showed the technician observed "Gaps on all exterior doors - All man doors and roll up doors have gaps at the bottom of the entrance allowing insect and rodent presence."
- Report dated 04/30/2020 showed the technician observed “food product all over the floor that is giving insects and rodents a food source, weeds around the structure, damaged food inside multiple opened containers and pallets of food located on the north and west side of the building, and multiple pallets stored too closely to the north wall of the facility giving rodents and insects harboring areas." The technician recommended that the firm "clean up the property."
- Report dated 06/05/2020 showed rodent activities and cat activities inside the warehouse. Technician noted no changes to the containers (doors kept open) and improper storage throughout the perimeter wall and exterior of the building as observed on 04/30/2020. Technician also noted "heavy pigeon activity and droppings" and that he found a litter of cats inside of the warehouse that were being fed by employees. It was noted that areas were not being cleaned and sanitized as needed and that there was a need to re-evaluate the account to continue to provide their services to this site.
- Report from 08/07/2020 showed rodent activity and cat feces throughout the facility. Technician observed and noted a cat sleeping on “expired pallets” and heavy cat droppings on the west side of the building between the cooler and the west side interior walls. Technician noted that there were still pallets and shipping containers with damaged and outdated product being stored outside that needed to be removed.
- Reports in 2021 consistently showed rodent activities, cat droppings in the warehouse, pallets with food leading to pest harborage/attractant, in addition to activities of Oriental and Turkistan roaches, ants, and bats. On 06/14/2021, the technician noted that he "found a pallet of cornmeal near trap 7 that was infested with stored product pest" and that "this pallet should be removed immediately." Also, on 08/26/2021, the technician noticed "Indian meal moth activity that is most likely coming from old, expired product that is sitting in the warehouse." On 10/25/2021 and 11/23/2021, the technician noted some of the traps were inaccessible for inspection.
- Reports dated 04/22/2022, 03/22/2022, 02/22/2022, and 01/24/2022 showed the technician repeatedly stated: “Gaps on all exterior doors[.] [A]ll pedestrian doorways and roll up doors have gaps at the bottom of the entrance allowing insects and rodent presence. Food product throughout the warehouse[.] [T]here is food product all over the floor that is giving insects and rodents a food source. Damaged food on the north and west side of the building[.] [T]here are multiple shipping containers that are opened with damaged food product[,] and there are multiple pallets that are damaged with food product on it. On the north side of the facility there are multiple pallets that are too close to the structure giving rodents and insects harboring areas.”
FDA collected several samples during the inspection (samples 1184925, 1176915, 1182925, 1183037 and 1183038). These samples were submitted to FDA labs for analysis. Results demonstrate that submitted product [including (b)(4) (split chickpeas) and (b)(4) brand Paprika] were contaminated with rodent/mouse hairs, cat hair and urine, urine stains (on packaging), gnaw marks, REPs as well as various species of larval, pupal, and adult insects. Further, sample 1184925 had evidence of insect penetration and damage to packaging and product as well as urine stains and yeast. The filth samples further demonstrated the presence of rodents and insect activity throughout the facility through the presence of rodent hairs, teeth marks, in pellet morphology and nesting materials as well as confirmation of various species of insects at larval, pupae and adult stages.
Your June 7, 2022, written response indicated that you contracted with a new third-party pest control provider and increased service frequency (b)(4) a month. In addition, you described a treatment plan to gain control of your facility and remove all pest activity from the interior and exterior. Further, you provided service reports dated 05/26, 05/27, 05/31, and 06/03/2022; however, these reports do not show the frequency for routine service. Also, you did not provide confirmation of other actions promised by your response, such as (b)(4) application over a (b)(4) period, a (b)(4) rodent trapping program, and establishment of a bat exclusion program.
In addition, your response indicated that all gaps and holes in doors have been repaired to eliminate pest route of entry. Further, you stated all areas of the facility, including warehouse, dry storage, walk-in freezer and packing room have been cleaned to remove rodent, animal, and insect filth. You also indicated that all affected product (damaged, expired, or containing urine stains or REPs) has been removed and discarded and that pallets have been moved away from walls for accessibility. However, you did not provide documentation to demonstrate repairs were made and the effectiveness of cleaning and pest removal, with the exception of the dry storage room. Further, you did not indicate how you plan to continue to maintain the facility and equipment in a sanitary condition.
2. You failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant, as required by 117.20(a)(1). Specifically,
- On May 9, 12, 16-19, and 23, 2022, piles of damaged pallets, pipes, garbage and boxes of food products (including (b)(4) brand mango juice drinks and (b)(4) brand mango fruit nectar drinks) were along the north side of the building, by the dumpsters in the parking lot at the east end of the warehouse
- On May 12, 17-19, and 23, 2022, at least (b)(4) pallets of boxes of food product (including (b)(4) brand fun snacks rice bites and Shan brand Shoop Instant noodles) were located at the northwest end. Bird feces was on the concrete pavement around the pallets of products.
- On May 12, 17-19, and 23, 2022, several piles of broken pallets, unused equipment, and garbage were all along the fence line outside the west end of the firm.
- On May 12, 17-19, and 23, 2022, three opened shipping containers, located outside at the west and northwest ends of the warehouse, each contained pallets of dirty and damaged boxes and bags of food products. Some bags and boxes were torn open where food product spilled out on to the floor and outside of the containers. All products within all three containers were haphazardly arranged, immediately adjacent to each other, and up against the sides of the containers. There were no aisles between products that would allow for a visual inspection within any of the containers.
- On May 9, 12, 16-19, and 23, 2022, overgrown weeds spanned along the fence lines at the north and northwest sides of the warehouse.
- On May 17, 2022, one live adult cat and 5 kittens were observed on top of a pallet of boxes of Falak brand basmati rice stored in an opened shipping container located outside of the warehouse at the west end.
In addition, on May 12, 2022, the following food products slated for destruction were located outside on your grounds:
- (b)(4) pallets containing boxes of prepackaged drinks were observed stored outside at the northeast wall.
- (b)(4) pallets of boxes of food products (including (b)(4) Brand fun snacks rice bites and Shan brand Shoop instant noodles) were observed outside at the northwest wall.
- (b)(4) opened shipping containers, (b)(4) at the northwest wall and (b)(4) at the west wall, all containing stacks of bags of dirty, dusty food products including legumes and pallets of boxes of food products including basmati rice that were observed immediately next to each other and up against the walls. There were no aisles in between products that would allow for a visual inspection of the containers. You did not start destroying products until May 23, 2022, after CDPH placed your firm under a blanket embargo on May 17, 2022.
Your Inventory Controller could not provide an estimate as to how long the food slated for destruction had been kept outside. This employee stated that dumpsters were ordered but could not give a time frame as to when they would arrive.
Further, on May 23, 2022, hundreds of apparent REPs were found around all 6 downspouts of the gutter drainage systems outside and along the south wall of the firm. At least 100 apparent REPs were found around the downspout nearest to the visitor’s entrance of the firm. At least 300 apparent REPs were found around the 3rd downspout located at the center of the south wall. Apparent rodents were heard moving about the inside of the piping system that led this downspout.
Your June 7 response stated that all food product and food debris have been discarded from the yard area damaged pallets and materials have been removed, and the grounds have been cleaned to remove pests, litter, trash, spoiled food, and feces. You also indicated that four storage containers have been emptied, cleaned and the product discarded. However, you did not provide documentation to demonstrate that these activities were performed, with the exception of one photograph of the grounds along an unidentified exterior wall. Further, you did not indicate how you plan to continue to maintain your yard in a sanitary condition.
Your written response also described processes established for the management of product slated for destruction. We are not able to fully evaluate the adequacy of this corrective action as you did not provide supporting documentation of its implementation.
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). Insanitary conditions around your facility demonstrated that sanitation and housekeeping operations were inadequate because your facility provided food sources and pest harborage areas for rodents and other pests which led to widespread product contamination. In addition, inadequate maintenance to parts of the facility allowed for potential pest entry and harborage areas within the facility. Specifically, during the inspection, on May 9, 2022, your firm identified 28 products that may be repacked in a dedicated room at your firm. Among these items are cashews, almonds, cumin powder, cloves, cinnamon, cardamom, and coriander that may be ready-to eat (RTE) and (b)(4) packaged by employees within an open environment. The following was observed in your repack room during the inspection:
- On May 9, 12, 16-19, and 23, 2022, buildup of dirt and dust debris on all (b)(4) hoppers/product filling equipment, scales, and shelves. Food debris, including garbanzo beans, was observed inside, and dusty dirty kidney beans and legumes were observed around the framing of one of the hoppers.
- On May 9, 12, 16-19, and 23, 2022, food products, including bay leaves, fennel seeds, and legumes, were spilled on the floor and on pallets about the room.
- On May 9, 12, and 16-19, 2022, a pile of at least 30/4 oz. retail packages red legumes was on the floor near the entrance to the repack room.
- On May 9, 12, 16-19, and 23, 2022, empty drink containers and food packages were found on shelves and in between bags and boxes of food products.
- On May 9, 12, 16-19, and 23, 2022, opened bags of food products including spices and cashews were observed in a large pile on the floor and up against the south wall. Live and dead insects were observed on and inside of the opened bags of product.
- On May 9, 12, 16-19, and 23, 2022, a (b)(4) sink and an adjacent white sink were located at the east end of the room. Both had a build-up of dust and dirt, and a spider web spanned across one basin of the (b)(4) sink. There was no soap, towels, or other means to dry hands at either sink. Your Inventory Controller stated the sinks are not used.
Your June 7 response stated the packing room and equipment within have been cleaned and sanitized to remove dust and food debris. You also indicated that all infested product has been removed and discarded. Further, packaging materials have been cleaned. FDA will evaluate the adequacy cleaning and sanitation practices during our next inspection of your facility. Your written response described re-packing and record keeping processes which have been created; however, we are not able to fully evaluate the adequacy of this corrective action as you did not provide supporting documentation of its implementation.
4. You did not provide employees with adequate, readily accessible, and clean toilet facilities to prevent a potential source of contamination of food, food-contact surfaces, or food packaging materials, as required by 21 CFR 117.35(d). Specifically:
- On May 9, 12, 16, 17 and 23, 2022, the faucet, located inside the restroom, of the designated handwashing sink was covered with plastic wrap obstructing the use of the sink. There were no soap, towels, or other means to dry hands at this sink.
- On May 9, 12, 16, 17 and 23, 2022, within the janitorial area, between the 2 toilets in the room, there was a sink, located in the restroom, that did not have towels or other means to dry hands, and there was no soap but rather a bottle of shampoo next to the faucet.
Your June 7 response stated that the employee and office bathrooms have been cleaned and fully stocked with hand soap, paper towels, toilet paper and seat-covers. It also stated that all sinks have been repaired, have hot and cold running water, and are stocked with hand soap and paper towels. Although you provided photographs which show the re-packaging equipment appears to be in sanitary condition, you did not provide photographs or other evidence to demonstrate the condition of the room or sinks. Also, you provided photographs to show a restroom and handwash station were cleaned and stocked appropriately; however, the locations are unknown. Further, you did not indicate how you plan to continue to maintain the facility (including bathrooms) in a sanitary condition. FDA will evaluate the adequacy cleaning and sanitation practices during our next inspection of your facility.
1. Your 100% Pure Desi Ghee product is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)] in that the finished product label fails to declare the major food allergen, milk. According to the label, this product is made from “Pure Grade AA Clarified Butter”, which is made from milk. We point out that in your response to the 483 (corrective action plan), there was no mention of correcting the labels.
2. Your 100% Pure Desi Ghee product is misbranded within the meaning of section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)] because there is a large discrepancy between serving size and servings per container information provided in the Nutrition Facts Label, when compared to the declared net quantity of contents. The net quantity of contents is double what would be calculated for the net quantity based on the information in the Nutrition Facts Label. If the declared serving size of 13g is multiplied by the declared 35 servings per container, the result is 455g, which is about one pound. However, the net quantity of contents for the product is declared as 2lb (32 FL OZ).”
3. Your 100% Pure Desi Ghee product is misbranded within the meaning of section 403(q) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(q)] because the serving size is not based on the appropriate RACC in accordance with 21 CFR 101.12(b)] and (21 CFR 101.9(b); therefore, all of the values in the nutrition label are incorrect. The label indicates a serving of “1/2 cup” (13 g). The RACC for this product is under the category “Butter, margarine, oil, shortening” and has a reference amount of 1 tbsp and a label statement of “1 tbsp (g) or 1 tbsp(15 mL).” Furthermore, we question whether ½ cup of this product would weigh 13 grams.
4. Your 100% Pure Desi ghee product is misbranded within the meaning of section 403(f) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(f)] because “desi” is a Hindi term; therefore, all required (mandatory) labeling must also be in Hindi, in accordance with section 21 CFR 101.15(c)(2).
The violations cited in this letter are not intended to be an all-inclusive list of the 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 your facility 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 do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Additionally, we reviewed your Shah Brand ghee product label and offer the following comments:
Ghee is obtained from milk, cream or butter by removing the non-fat milk solids and water, and it typically contains about 99.6% or more milk fat (Codex Standard CXS 280-1973). Ghee is not considered a highly refined oil and is not exempt from major food allergen labeling requirements. Since ghee is prepared from milk, a major food allergen, the label must declare milk as the name of the food source from which the major food allergen is derived.
The amount of non-fat milk solids, including milk proteins, present in ghee can vary depending on manufacturing process. The protein content of the ghee product must be determined for better evaluation of the risk posed by milk proteins remaining in ghee. The protein content in the Shah Brand ghee product is not known. The Nutrition Facts panel of its label indicates a serving size of ½ cup (13 g) and 7g protein, which do not appear to be accurate. A search for nutrient composition of ghee at USDA database indicate 0.28% protein in ghee1. This is equivalent to 0.039 g (39 mg) milk protein in a portion of 14 g (1 tablespoon) ghee. The current science on allergen risk assessment is based on population minimal eliciting dose (ED) distributions, which can be used to determine ED01 and ED05 doses at which 1% and 5% of the allergic population, respectively, can be expected to have allergic reaction1. Remington et al (2020)22estimated ED01 and ED05 for milk protein to be 0.2 mg and 2.4 mg, respectively, which is considerably lower than the milk protein that could be expected in 1 tablespoon of ghee. It can be anticipated that a serving size of 1 tablespoon ghee with 39 mg milk protein can possibly cause allergic reaction in over 25% of milk allergic population based on the ED25 of 32.7 mg for milk protein reported by Houben et al (2020)33. We consider the milk proteins remaining in ghee can pose a significant concern of allergic reaction in milk allergic population.
We also note the following:
- There is inconsistency within your label’s net quantity of comments statement in that it lists both “NET WT.” and “FL OZ.” 21 CFR 101.7(a).
- The information panel is not immediately to the right of the principal display panel, as required by section 21 CFR 101.2.
- The street address for your firm is not provided. In accordance with section 21 CFR 101.5(d), the street address is required unless it is shown in a current city directory or telephone directory.
- The trans-fat declaration is not expressed in the correct increment as required by section 21 CFR 101.9(c)(2)(ii), and the vitamins and minerals are not declared in accordance with the new Nutrition Facts label (NFL). 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. For more information on the new requirements, please see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter, as to the specific steps that you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documentation. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 635805 when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at firstname.lastname@example.org or (949) 608-2967.
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
1 USDA website link FoodData Central (usda.gov).
2 Remington et al, 2020, Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens. Food and Chemical Toxicology, 139: 111259.
3 Houben et al, 2020, Full range of population eliciting dose values for 14 priority allergenic foods and recommendations for use in risk characterization. Food and Chemical Toxicology, 146: 111831.