Florida Gold Foods LLC MARCS-CMS 637153 —
- Delivery Method:
- VIA Electronic Mail
- Food & Beverages
Recipient NameMr. Ragindra Persaud
- Florida Gold Foods LLC
1770 and 1780 Business Center Lane
Kissimmee, FL 34758-1800
- Issuing Office:
- Division of Human and Animal Food Operations East IV
23-HAFE4-WL-01/CMS No. 637153
Dear Mr. Persaud and Mr. Sew:
The United States Food and Drug Administration (FDA) in conjunction with Florida Department of Agriculture and Consumer Services (FDACS) conducted an inspection of your facility, located at 1770 and 1780 Business Center Lane, Kissimmee, Florida from May 11, 2022 through May 31, 2022, where you re-pack and distribute milled rice products. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP rule & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). During the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent excreta pellets, multi-stage beetles (adult and larvae), fecal material that contained cat/dog hairs, and insects including flies and moths present throughout your facility. Additionally, FDA collected samples from your Florida Gold brand 2-lb bags of rice and performed a filth analysis which revealed various species of insects at larval, pupae and adult stages present in the sample. 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.
Based on inspectional and analytical findings, we determined that 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 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 further information about the CGMP & PC rule through links on FDA’s homepage at www.fda.gov.
On May 12, 2022, based on the finding of the current inspection, FDACS placed all products in building (b)(4) and building (b)(4) under Stop Sale Order and your equipment under a Stop Use Order. On August 26, 2022, in response to the current inspectional findings and under FDACS’s oversight, you completed your voluntary destruction of all products and packaging within both buildings.
However, to date, we have not received your written response to the issued FDA-483 describing corrective actions taken by your firm or changes you are making to your business operations. You informed our FDA investigators at the close of our inspection that your business plans to sell the facility and cease food manufacturing and storage. However, FDA’s import records reflect that on August 3, 2022 and September 23, 2022, you received shipments of Parboiled Rice in which you were identified as the consignee and your current facility location was listed. To date, your facility website is still active. Further, it is our understanding that you have not filed the articles for dissolution of your LLC, and you have not canceled your food facility registration with FDA. We are issuing this letter to advise you of FDA’s 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 were observed throughout your facility including the following:
a. Rodent Activity observed:
i. In building (b)(4), 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 (b)(4) 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 (b)(4); along the perimeter walls of buildings (b)(4) and building (b)(4); and between pallets of repacked bagged rice, totes of bulk rice, on empty cardboard boxes, on boxes with packaging material in buildings (b)(4) and building (b)(4); 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 (b)(4), investigators observed at least five (5) live rodents throughout the processing and storage areas. Of the live rodents, two (2) 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 (b)(4), and two (2) 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 (b)(4).
iii. Investigators observed numerous areas with apparent fluorescing rodent urine stains located in the northwest corner of the building (b)(4) on the floor next to pallets of milled rice to be reworked and on the west side of building (b)(4) 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 (b)(4) 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 (b)(4) and (b)(4), 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 (b)(4) machine, two (2) (b)(4) machines, (b)(4) 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 (b)(4) 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 (b)(4), investigators observed four (4) or more live cats in the northern end of the building and apparent cat feces and urine throughout the warehouse.
ii. In building (b)(4), investigators observed one (1) rodent carcass near the packaging equipment on the eastern side of the building.
iii. Investigators observed a cat running from building (b)(4) with a rodent in its mouth.
FDA analyzed several samples for filth which were collected during our inspection from various areas within your warehouse facility (samples 1167660, 1178228, and 1182068) and a sample of your Florida Gold brand 2-lb bags of rice (sample 1180611). 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 your 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 (2) 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. 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. In addition, inadequate maintenance of parts of the facility allowed for potential pest entry and harborage areas within the facility.
a. In building (b)(4) investigators observed the following:
i. Filth, debris, and pests were on and in milled rice processing equipment located on the (b)(4) 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 (b)(4) 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 (b)(4) at the top edge of the vent pipe in the processing equipment area in the northwest corner of the building.
v. The (b)(4) door nearest the southwest corner of the building had a gap approximately (b)(4) inches high along the bottom of the door.
b. In building (b)(4) 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 (b)(4) inches high along the bottom of the door.
vi. There were two (2) open pipes emerging from the floor in the (b)(4) of the building that were surrounded by insects and apparent rodent excreta pellets. There were two (2) holes approximately (b)(4) on the interior wall within (b)(4) 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 (b)(4) and (b)(4), 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 violations cited in this letter are not intended to be an all-inclusive list of the violations that may 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 address 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.
Please notify this office in writing within 15 working days of the receipt of this letter as to the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.
Your written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon A. Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. You may email a copy of your response with appropriate attachments to the email address: firstname.lastname@example.org. Please ensure your firm name, Firm Establishment Identifier (FEI), and establishment address are included in the correspondence. If you have any questions regarding this letter, please contact, Ms. Gina Eng, Compliance Officer, at (561) 416-1065 ext. 1114 or via email at Gina.Eng@fda.hhs.gov.
Ramon A. Hernandez
District Director | FDA San Juan District Office
Program Division Director
Office of Human and Animal Food Operations East Division 4