- Poinciana Milling Complex
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
September 17, 2014
Omawattie “Jean” Badley-Hakh
Poinciana Milling Complex, Inc.
1770 Business Center Lane
Kissimmee, FL 34758-1800
Dear Mrs. Badley-Hakh:
The Food and Drug Administration (FDA) conducted inspections at your food facility, located at 1770 Business Center Lane, Kissimmee, FL 34758 on June 23-26, 2014; July 1 and 21, 2014; and August 5-6, 2014. During the inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). The inspection revealed that food stored at your facility is 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 the food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth.
In addition, samples collected during the inspection and analyzed by FDA's Southeast Regional Laboratory confirmed the presence of insects, including but not limited to, sawtoothed grain beetles (larvae, pupae and cast skin). Their presence causes the product to be adulterated within the meaning of Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(3)] in that it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov
The investigators provided you with a Form FDA 483, Inspectional Observations, which delineated a number of gross insanitary conditions and CGMP violations observed during the inspection, including:
1. Live and dead insects including sawtoothed grain beetles, Oryzaephilus surinamensis; Indian Meal Moths, Plodia interpunctella; a flat grain beetle, Crytolestes pusilus; a red flour beetle, Tribolium castaneum; and an Australian cockroach, Periplanta australasiae; were observed in, on, and near food stored throughout your facilities.
2. You failed to ensure that rubbish is conveyed, stored and disposed of to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding places for pests, and protect against the contamination of food, food-contact surfaces, water supplies, and ground surfaces, as required by 21 CFR 110.37(f).
- Approximately 600-700 metric tons of rice stored outside of Building 1780 was covered with tarps with tears exposing at least 5 totes. The exposed totes contained what appeared to be moldy rice. Green standing water was present on and around the tarps covering these totes. Spilled rice on the ground around the totes contained numerous beetle-type insects at various stages of life.
- A foul odor emanated from an uncovered wooden trash receptacle between Buildings 1770 and 1780 containing used rice bags and miscellaneous trash. This receptacle was located approximately six feet away from a dust cyclone connected to Building 1770. A gap above the pipe connecting the cyclone to the building could serve as an entry point for pests.
3. Failure to have smoothly bonded or well-maintained seams on food contact surfaces, to minimize accumulation of food particles and the opportunity for growth of microorganisms as required by 21 CFR 110.40(b). Metal sheeting lined equipment that lacked smoothly bonded seams preventing product buildup and ease of cleaning.
4. You failed to ensure that plant equipment and utensils are of such material and workmanship as to be adequately cleaned and properly maintained, as required by 21 CFR 110.40(a).
- Milling equipment surfaces in direct contact with your products included wood, cardboard and denim materials.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
Additionally, Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility.
The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.
Susan M. Turcovski
Director, Florida District