- Iberia Foods Company of New York, Inc
- Issuing Office:
- New York District Office
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
July 31, 2014
WARNING LETTER NYK-2014-53
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Eric S. Miller, CEO and President
Iberia Foods Company of New York, Inc.
1900 Linden Boulevard
Brooklyn, New York 11207
Dear Mr. Miller:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your food storage facility, located at 1900 Linden Boulevard, Brooklyn, New York between May 13 and 20, 2014. During the inspection, FDA investigators documented serious violations of Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice (CGMP) regulations. The inspection revealed that the condition of your facility caused the foods therein to be adulterated under Section 402(a)(4) [21 United State Code (USC) 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) because the food had been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth. You can find the Act and the regulations through links in FDA's Internet Homepage at www.fda.gov
The following significant deviations were observed during the inspection:
1) Your firm failed to take effective measures to exclude pests from your warehouse areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). For example, the following observations were noted during this inspection:
- Approximately six live birds were observed flying throughout the facility.
- Three dead and one dying bird were observed trapped in netting suspended in the facility.
- Birds were observed flying onto pallets containing damaged bags of rice and eating the exposed rice.
- Apparent bird excrement was noted on packaging materials and finished products stored within the warehouse.
- One bird was observed on the outside of an open window behind a large metal grate. The bird appeared to be able to pass through the grate and was observed to be carrying packing material in its beak.
- A bag by bag examination was conducted on a pallet of 50# Iberia brand parboiled long grain white rice imported from (b)(4). Product was stored under a partially working light near the loading bay on the Eastern side of the facility. Laboratory evaluation of FDA Sample 856746 collected during this examination confirmed the presence of rodent excreta pellets and rodent hairs on the surface of 2 bags of this product.
- Approximately 50 dull apparent rodent excreta pellets were observed along the northern wall of a large room at the north eastern section of your facility.
- Soft/dull appearing apparent rodent excreta pellets too numerous to count were observed along the eastern wall of the large room at the north eastern section of the facility.
- Apparent rodent nesting material was found within a pile of broken chairs covered by a large blue tarp within the room at the north eastern section of the facility. The tarp appeared to have extensive rodent gnaw marks at several locations.
- Approximately 5 dull appearing apparent rodent excreta pellets were observed in the southeastern corner of the facility.
- Approximately 6 dull appearing apparent rodent excreta pellets were observed in the southwestern corner of the facility.
- Approximately 20 dull appearing apparent rodent excreta pellets were observed in the northern section of the facility.
- Approximately 50 dull appearing apparent rodent excreta pellets were observed in the north eastern section of the facility.
- Apparent rodent nesting material, excreta pellets and footprints were noted within multiple pallets of cardboard packaging material.
We acknowledge receipt of your letters dated May 20, 2014 and June 4, 2014 signed by Vanessa Vazquez-Frank, Esq. (attached) responding to the violations noted. We note your intentions to take corrective action by contracting the services of a pest control company and bird remediation company. However, your response does not address the examination and disposition of any products found to be affected by rodent or bird contamination. The later response indicates products are examined upon fulfillment of an order, but this does not address the removal of contaminated or open product which may serve as continued harborage for pests. With respect to bird activity, the netting does not keep birds out of your facility or prevent bird excrement from falling onto stored products as evidenced by the observation of multiple birds flying onto pallets of open rice and excrement directly on products. We also note that these conditions have been reported to you during several prior inspections.
2) Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). For example, the following observations were made during the inspection:
- Windows in the facility were observed open.
- Two metal grates located directly behind the above lot of rice were observed to be damaged. These grates led directly to the street.
We acknowledge the intent to address structural concerns addressed in your May 20, 2014 response. However, we note that similar violations have been reported to your firm in prior inspections. Future inspections will determine the adequacy of your corrective action.
3) Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a). For example, the following observations were made during the inspection:
- Several areas of the facility had broken and spilled product on the floor, including rice and unidentifiable liquid foods.
- The basement contained large amounts of unused partially broken equipment preventing a proper inspection of the room and providing potential harborage areas for rodents.
- The floor of the basement was coated with unidentifiable residue which appeared to be oil based.
- Lots of canned goods were noted to have debris directly on top of cans consisting of broken ceiling tiles, spilled liquid products and broken glass.
We acknowledge the intent to address structural defects as relayed in your May 20, 2014 response. Again, these are repeat issues. Future inspections will determine the adequacy of your corrective action.
4) Your firm failed to maintain adequate floor drainage in all areas where floors are subject to flooding or where normal operations release or discharge water on the floor as required by 21 CFR 110.37(b)(4). For example, the following observations were made during the inspection:
- Large amounts of standing water were observed throughout the basement. Multiple points were noted to have standing water approximately 2-3 inches deep.
- Areas of the basement were also noted to have water damage as high as approximately 2 feet off the ground indicating a history of flooding.
We acknowledge the intent to repair sump pumps as relayed in your May 20, 2014 letter. Your June 4, 2014 claims your facility never had flooding up to 2 feet high. Flooding or standing water at any level is not acceptable. Again, this is a longstanding issue noted during several prior inspections. Future inspections will determine the adequacy of your corrective action.
The violations cited in this letter may not be all-inclusive of violations which exist 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 that your firm complies with all requirements of Federal law and FDA regulations. Failure to implement lasting corrective actions on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating. Other federal agencies may take this warning letter into account when considering the award of contracts.
You are requested to notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to prevent the recurrence of violations or similar violations. Please explain and include documentation of any additional corrective action you have taken. If additional planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
In addition, the FDA has determined that your facility is subject to the registration requirement in Part 415 of the Act [21 USC 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the May 13-20, 2014 inspection, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Part 301(dd). Our records indicate that, to date, your facility has failed to renew your registration and it has since been cancelled. As a responsible official of a facility which manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring your overall operation and the products you distribute are in compliance with the law. We request that you or an individual you authorize to register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished on-line at www.fda.gov, under the Food Registration heading. We strongly encourage the use of electronic registration, but alternatively, you may request the Form 3537 by calling the FDA Industry systems Help Desk at 1-800-216-7331. When completed, the form may be faxed to (301) 210-0247.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 re-inspection-related costs.
Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov
Ronald M. Pace
New York District