Kandagis Inc. d.b.a. Gourmet Factory 8/31/15
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
August 31, 2015
WARNING LETTER NYK-2015-51
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUEST
Mr. Themis Kangadis, President
Kangadis Inc. d.b.a. Gourmet Factory
55 Corporate Drive
Hauppauge, NY 11788-2021
Dear Mr. Kangadis:
Between April 15 and 30, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 55 Corporate Drive, Hauppauge, New York.
The inspection revealed serious violations of the regulations for acidified foods (Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114)). Accordingly, we have determined that your acidified food products 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 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 can find the Act and the Acidified Food regulations, through links in FDA's home page at http://www.fda.gov.
As an acidified food processor, you are required to comply with the Act and the federal regulations relating to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR Part 108, Emergency Permit Control, and in 21 CFR Part 114, Acidified Foods. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act (21 U.S.C. § 344). A temporary emergency permit may be required for acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR 114.
We acknowledge your written response, dated May 15, 2015, to the Form FDA 483, List of Inspectional Observations that was issued to your firm at the conclusion of our inspection. We have reviewed your response and concluded that it lacks sufficient corrective actions. Our comments are listed below.
During our inspection, we observed the following significant violations:
1) As a commercial processor engaged in the thermal processing of acidified foods you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative level, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).
Specifically, your firm does not have scheduled processes on file for the acidified food products you manufacture, including, but not limited to, your chopped garlic in oil and chopped garlic in water in 128oz and 32oz clear plastic jars. We acknowledge that your firm submitted scheduled processes on June 19, 2013; however, these processes were returned online by FDA on July 22, 2013, because they did not include a thermal heat treatment step sufficient to destroy vegetative cells of microorganisms of public health significance as required by 21 CFR 114.80(a)(1). Alternatively, your firm did not provide challenge studies to support a 5-log reduction in these vegetative cells of microorganisms.
Your written response, dated May 15, 2015, states that you are working with your process authority to correct this violation; however, at this time, we have not received any updated scheduled process submissions from your firm.
2) Your firm failed to establish a scheduled process by a qualified person who has expert knowledge acquired through appropriate training and experiences in the acidification and processing of acidified foods, as required by 21 CFR 114.83.
Specifically, your firm’s processes for chopped garlic in oil and chopped garlic in water in 128oz and 32oz clear plastic jars were not established by a competent authority with expert knowledge in the processing of acidified food products.
Your firm’s response, dated May 15, 2015, states that you will review your entire garlic process and will work with process authorities to review results of your stability testing and the scheduled process; however, we have not received any further documentation demonstrating that you have revised your scheduled processes.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the FD&C Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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 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 U.S.C. § 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.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: LCDR Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact LCDR Jackson at (718) 662-5711.
Ronald M. Pace
New York District