As part of its enforcement efforts, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are only made publicly available weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warnings are often only issued after a company has been given months or years to fix problems.
Florida Gold Foods LLC
Kissimmee, FL
A Florida food company has been notified by the U.S. Food and Drug Administration (FDA) after rodent, insect and animal activity was observed at its facility.
In a warning letter dated November 22, 2022, the FDA described a May 11-31, 2022 inspection of the Florida Gold Foods LLC facility by the FDA in cooperation with the Florida Department of Agriculture and Consumer Services (FDACS), where they resumed packaging and distribution of milled rice products in Kissimmee, FL.
The FDA’s inspection found that the company had serious violations of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and resulted in the issuance of an FDA Form 483.
Some of the major violations are as follows:
Current Good Manufacturing Practice
1. The company has not taken effective measures to keep vermin out of its packaging and storage areas and to protect against contamination of food on premises by vermin. Specifically, rodent, insect, and animal activity has been observed throughout the facility, including the following:
a. Rodent activity observed:
I. When building (redacted), investigators observed apparent pellets of rodent excrement (too numerous to count) on bulk containers of milled rice that should be reworked. At least 30 of approx (redacted) these bulk containers of post-processing ground rice had openings or broken areas on the top of the bag where the rice was exposed. Investigators observed apparent rodent fecal pellets (too numerous to count) on and in indoor processing plants (redacted); on the outer walls of buildings (redacted) and buildings (redacted); and between pallets of repackaged rice in sacks, bins of loose rice, on empty boxes, on boxes of packing materials in buildings (redacted) and buildings (redacted); and on pouches intended for use as end product packaging that are manufactured and marked by the company for use by other companies.
ii. When building (redacted)Investigators observed at least five live rodents in the processing and storage areas. Of the live rodents, two rodents were observed under pallets of loose rice for post-processing in the area adjacent to the processing equipment at the north end of the building (redacted), and two rodents were observed at the south end of the building, walking around the facility and between pallets of large rice bins. Investigators also observed what appeared to be a newborn rodent lying between 50-pound sacks of jasmine rice at the south end of the building (redacted).
iii. Investigators observed numerous areas of what appeared to be fluorescent urine stains from rodents in the northwest corner of the building (redacted) on the ground next to pallets of ground rice to be processed and on the west side of the building (redacted) on pallets containing bulk containers of milled rice to be disposed of and within 2 feet of bulk containers of milled rice to be repackaged or redistributed. Apparent fluorescent urine stains from rodents were also observed on the north side of the building (redacted) on old equipment that is to be used for parts, on unused boxes in which packing materials and other items are kept, and on packaging materials such as bags or rice sacks.
b. Observed insect activity:
I. Everywhere in buildings (redacted) and (redacted)Investigators observed dead and live insects (too numerous to count) such as apparent moths, beetles, weevils and spiders inside the in-process product to be reworked on and inside processing equipment such as that (redacted) machine, two (redacted) Machinery, (redacted) Machinery and all equipment around both buildings that is either used for the milling process or stored for parts. There were also obvious flies and mosquitoes flying around inside and outside the buildings. In addition, cockroaches were observed in the building (redacted) on and around soiled pots and pans with leftover food in the staff shower room at the south end of the building.
c. Observed animal activity:
I. When building (redacted)Investigators observed four or more live cats at the north end of the building and apparent cat feces and urine throughout the warehouse.
ii. When building (redacted)Investigators observed a rodent carcass near the packing facility on the east side of the building.
iii. Investigators observed a cat running out of the building (redacted) with a rodent in its mouth.
i.e. rehearse
The FDA analyzed several samples for dirt collected during its inspection from various areas within the company’s storage facility, as well as a sample of its 2-pound Florida Gold brand rice bags. These samples were submitted to FDA laboratories for analysis. Results from Florida Gold brand 2 pound bags of rice show that this product has been adulterated with various species of insects in the larval, pupal and adult stages, including multi-stage dead beetles, sawtooth beetles and red flour beetles. In addition, samples collected at their facility resulted in numerous debris finds including the presence of rodent fecal pellets of a size implying a rat, fecal material with internal cat/dog hair, rat/mouse hair, two feathers identified as songbird feathers, multi – Beetles (adults and larvae) and insects including but not limited to flies and moths. The soil samples further demonstrate the presence of rodents and insect activity throughout the facility through the presence of rodent hair and in pellet morphology, as well as confirmation of various insect species in larval, pupal and adult stages.
2. The company has not kept its facility in a clean and sanitary condition and has not maintained its facility adequately to prevent food adulteration. Unhygienic conditions around the facility indicated that sanitation and housekeeping were inadequate as the facility provided food sources and vermin shelter for rodents and other vermin. In addition, poor maintenance of parts of the facility allowed for potential pest intrusion and hideout areas within the facility.
a. When building (redacted) Investigators found the following:
I. Dirt, debris and vermin were found on and in milled rice processing equipment that was on the (redacted) of the building.
ii. Numerous milled rice processing equipment were in poor condition due to tape and peeling paint on food contact surfaces.
iii. There were numerous holes and gaps in the interior walls, including about one hole (redacted) on the wall next to the packing plant on the east side of the building.
IV. There were holes leading to the exterior of the facility, including about a hole below (redacted) at the top of the vent pipe in the processing plant area in the northwest corner of the building.
v. the (redacted) The door closest to the southwest corner of the building had about a gap (redacted) inches high along the bottom of the door.
b. When building (redacted) Investigators found the following:
I. Dirt, debris and vermin were found on and in non-functioning equipment throughout the building, which was stockpiled for parts.
ii. Sacks of rice containing live and dead insects, intended for disposal, were stored alongside recently obtained milled rice.
iii. Thousands of screw-top plastic containers destined for disposal were dumped alongside recently obtained milled rice. We observed obvious pellets of rodent excrement (too numerous to count as described above) and other debris on and around the pallets of plastic bins.
IV. Other miscellaneous items (e.g. personal items such as shoes, pots and pans, cigarette butts, a washing machine, laundry detergent) were scattered throughout the building.
v. The bay door closest to the southeast corner of the building had about a gap (redacted) inches high along the bottom of the door.
vi. There were two open pipes sticking out of the ground (redacted) of the building surrounded by insects and obvious rodent droppings. It was about two holes (redacted) on the inner wall inside (redacted) Feet of the open tubes. Insulation was sticking out of one of the holes in the wall.
c. In the outdoor areas around and between buildings (redacted) and (redacted), there was a large number of pallets, stacks of empty rice containers, stacks of plastic screw-top containers, dumpsters overflowing with rubbish, unused rice milling and packing equipment, and numerous additional miscellaneous items (far too many to count). This lack of care has the potential to attract pests and become havens.
The full warning letter can be viewed here.
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