As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Gold Coast Distributors Inc. dba Shah Distributors
Owners of a food firm in California are on notice from the United States Food and Drug Administration (FDA) after rodents, cat urine, bats, oriental and Turkistan roaches, Indian meal moth and more were found in their facility.
In a Nov. 02, 2022, warning letter, the FDA described a May 9-27, 2022, inspection by the FDA of Gold Coast Distributors Inc.’s ambient and frozen warehouse and re-packing facility in Stockton, FL.
The FDA’s inspection revealed that the firm had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, and resulted in the issuance of an FDA Form 483.
Some of the significant violations are as follows:
Current Good Manufacturing Practice
1. The firm did not take effective measures to exclude pests from their packing and holding areas and to protect against the contamination of food on the premises by pests. Specifically, rodent, insect, and animal activity was observed throughout their facility including, but not limited to the following:
Rodent Activity observed:
Dry storage room at (redacted) 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 (redacted) 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 (redacted)/2 oz. retail bags of (redacted) 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 (redacted) 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 (redacted) of paprika.
- On May 9, 12, 16, and 17, 2022, one rodent gnawed cardboard case having REPs and rodent rub marks contained at least (redacted)/4 oz. retail bags of (redacted) 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 (redacted)/24 oz. bags of (redacted) 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 (redacted)/4 oz. retail bags of (redacted) 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 (redacted) tea sweetener and at least 9 rodent gnawed boxes labeled (redacted) 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 (redacted)/6 pack shrink wrapped packages of (redacted) 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 (redacted) boxes. At least 10 REPs were found on a box of the (redacted) 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 (redacted) brand basmati sela rice on a pallet containing (redacted) bags. One bag on this pallet had an apparent rodent gnawed hole approximately 3” x 3” that was surrounded by yellowish stains.
Inside (redacted) 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 (redacted) 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 (redacted) pallets each containing (redacted)/55 lb. bags of (redacted) (split chickpeas). Insect bored holes were observed in at least 4 bags of each pallet. (redacted) product below the bored holes appeared clumped with insect eggs and had crawling insects. These pallets were located on the (redacted) of pallet (redacted) 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 (redacted) pallets each containing at least (redacted)/20 lb. bags. Live and dead flying and crawling insects were observed on and in between the bags and shrink wrap of all (redacted) pallets. Two opened bags contained at least 6 winged and crawling insects. The (redacted) 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 (redacted) brand desiccated coconut. The bag was on a pallet of (redacted)/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 (redacted) 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 (redacted) 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 (redacted) instant mix) located at the north, south, and southwest ends of the warehouse. Animal paw prints were observed on boxes of (redacted) 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 (redacted) (split chickpeas) that were located on layers (redacted) pallet containing (redacted)/55 lb. bags. This pallet was located on the (redacted) of pallet (redacted). A bag of (redacted) 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.
Pest control records:
In addition to visual observations, FDA investigators conducted a review of the firm’s 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. These samples were submitted to FDA labs for analysis. Results demonstrate that submitted product [including (redacted) (split chickpeas) and (redacted) 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, a sample 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.
The firm 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. Specifically,
- On May 9, 12, 16-19, and 23, 2022, piles of damaged pallets, pipes, garbage and boxes of food products (including (redacted) brand mango juice drinks and (redacted) 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 (redacted) pallets of boxes of food product (including (redacted) 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 their grounds:
- (Redacted) pallets containing boxes of prepackaged drinks were observed stored outside at the northeast wall.
- (Redacted) pallets of boxes of food products (including (redacted) Brand fun snacks rice bites and Shan brand Shoop instant noodles) were observed outside at the northwest wall.
- (Redacted) opened shipping containers, (redacted) at the northwest wall and (redacted) 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. The firm did not start destroying products until May 23, 2022, after CDPH placed their firm under a blanket embargo on May 17, 2022.
The firm’s 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.
The firm 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. 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 bottlxe of shampoo next to the faucet.
The full warning letter can be viewed here.
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