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.
Florida Gold Foods LLC
A food firm in Florida is on notice from the United States Food and Drug Administration (FDA) after rodent, insect and animal activity were observed throughout their facility.
In a Nov. 22, 2022, warning letter, the FDA described a May 11-31, 2022, inspection by the FDA in conjunction with the Florida Department of Agriculture and Consumer Services (FDACS) of Florida Gold Foods LLC’s facility where they re-pack and distribute milled rice products in Kissimmee, 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 were observed throughout the facility including the following:
a. Rodent Activity observed:
i. In building (redacted), investigators observed apparent rodent excreta pellets (too numerous to count) on top of bulk totes of milled rice intended to be reworked. At least 30 out of approximately (redacted) of these bulk totes of milled rice for rework had openings or broken areas on top of the bag where the rice was exposed. Investigators observed apparent rodent excreta pellets (too numerous to count) on and inside processing equipment in building (redacted); along the perimeter walls of buildings (redacted) and building (redacted); and between pallets of repacked bagged rice, totes of bulk rice, on empty cardboard boxes, on boxes with packaging material in buildings (redacted) and building (redacted); and on bags to be used as finished product packaging that are fabricated and labeled by the firm for use by other companies.
ii. In building (redacted), investigators observed at least five live rodents throughout the processing and storage areas. Of the live rodents, two rodents were observed under pallets of bulk rice to be reworked in the area adjacent to the processing equipment on the northern end of building (redacted), and two rodents were observed in the southern end of the building running around the perimeter of the facility and in between pallets containing bulk totes of rice. Investigators also observed an apparent newborn rodent lying in between 50-lb bags of jasmine rice at the southern end of building (redacted).
iii. Investigators observed numerous areas with apparent fluorescing rodent urine stains located in the northwest corner of the building (redacted) on the floor next to pallets of milled rice to be reworked and on the west side of building (redacted) on pallets containing bulk totes of milled rice intended to be discarded and located within 2 feet of bulk totes of milled rice to be repacked or distributed. Apparent fluorescing rodent urine stains were also observed on the north side of building (redacted) on old equipment to be used for parts, on unused cardboard boxes which store packing materials and miscellaneous items, and on packing materials such as bags or rice sacks.
b. Insect activity observed:
i. Throughout buildings (redacted) and (redacted), investigators observed dead and live insects (too numerous to count) such as apparent moths, beetles, weevils, and spiders, inside in-process product to be reworked, on and inside processing equipment such as the (redacted) machine, two (redacted) machines, (redacted) machines, and all equipment around both buildings to be used either in the milling process or being stored for parts. There were also apparent flies and gnats flying around inside and outside of the buildings. Additionally, cockroaches were observed in building (redacted) on and around soiled pots and pans containing food residue in the employee shower room at the southern end of the building.
c. Animal activity observed:
i. In building (redacted), investigators observed four or more live cats in the northern end of the building and apparent cat feces and urine throughout the warehouse.
ii. In building (redacted), investigators observed one rodent carcass near the packaging equipment on the eastern side of the building.
iii. Investigators observed a cat running from building (redacted) with a rodent in its mouth.
FDA analyzed several samples for filth which were collected during their inspection from various areas within the firm’s warehouse facility and a sample of their Florida Gold brand 2-lb bags of rice. These samples were submitted to FDA labs for analysis. Results from the Florida Gold brand 2-lb bags of rice demonstrate that this product was adulterated with various species of insects at larval, pupae and adult stages including multi-stage dead beetles, sawtoothed grain beetles, and red flour beetles. Further, the samples collected from within their facility resulted in numerous filth findings including the presence of rodent excreta pellets of a size implicating a rat, fecal material with internal cat/dog hairs, rat/mouse hairs, two feathers identified as songbird feathers, multi-stage beetles (adult and larvae), and insects including but not limited to, flies and moths. The filth samples further demonstrate the presence of rodents and insect activity throughout the facility through the presence of rodent hairs and in pellet morphology as well as confirmation of various species of insects at larval, pupae and adult stages.
2. The firm did not maintain their plant in a clean and sanitary condition and keep their plant in repair adequate to prevent food from becoming adulterated. Insanitary conditions around the facility demonstrated that sanitation and housekeeping operations were inadequate because the facility provided food sources and pest harborage areas for rodents and other pests. In addition, inadequate maintenance of parts of the facility allowed for potential pest entry and harborage areas within the facility.
a. In building (redacted) investigators observed the following:
i. Filth, debris, and pests were on and in milled rice processing equipment located on the (redacted) of the building.
ii. Numerous pieces of milled rice processing equipment were in disrepair with tape and peeling paint on food contact surfaces.
iii. There were numerous holes and gaps on interior walls including a hole approximately (redacted) on the wall near the packaging equipment on the east side of the building.
iv. There were holes leading to the exterior of the facility, including a hole approximately (redacted) at the top edge of the vent pipe in the processing equipment area in the northwest corner of the building.
v. The (redacted) door nearest the southwest corner of the building had a gap approximately (redacted) inches high along the bottom of the door.
b. In building (redacted) investigators observed the following:
i. Filth, debris, and pests were on and in non-functioning equipment located throughout the building that was being stored to be used for parts.
ii. Bags of rice with live and dead insects that were intended to be thrown away were being stored alongside recently received milled rice.
iii. Thousands of plastic screw-top containers that were intended to be discarded were being stored alongside recently received milled rice. We observed apparent rodent excreta pellets (too numerous to count, as described above) and other filth on and around the pallets of plastic containers.
iv. Other miscellaneous items (e.g., personal items such as shoes, pots and pans, cigarette ends, a washing machine, detergents) were scattered throughout the building.
v. The bay door nearest the southeast corner of the building had a gap approximately (redacted) inches high along the bottom of the door.
vi. There were two open pipes emerging from the floor in the (redacted) of the building that were surrounded by insects and apparent rodent excreta pellets. There were two holes approximately (redacted) on the interior wall within (redacted) feet of the open pipes. Insulation was protruding from one of the holes in the wall.
c. In the exterior areas around and between buildings (redacted) and (redacted), there were large numbers of pallets, piles of empty rice totes, piles of plastic screw-top containers, dumpsters overflowing with garbage, unused rice milling and packaging equipment, and numerous additional miscellaneous items (all too numerous to count). This inadequate maintenance presents the potential to attract pests and become harborage areas.
The full warning letter can be viewed here.
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