Inspections, Compliance, Enforcement, and Criminal Investigations
MDK Enterprises, Inc dba Maui Jelly Factory 9/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94501-7070
Telephone: (510) 337-6700
September 5, 2012
Mr. Michael T. Kilinski, President
MDK Enterprises, Inc. dba Maui Jelly Factory and Maui Fudge & Ono Chocolates
32 Kumano Drive
Pukalani, Maui, HI 96793
Dear Mr. Kilinski:
The United States Food and Drug Administration (FDA) inspected your food processing facility located at 1464 Lower Main Street, Suite 104, Wailuku, Hawaii, between the following dates: May 5, 2012 and May 15, 2012. The inspection determined your facility produces an acidified food and revealed you have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114).
As a manufacturer of acidified canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified canned food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR Part 114). The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 U.S.C. § 344]. A temporary emergency permit may be required for low-acid canned foods and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35 and 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 114 and 21 CFR Part 113. In addition, based upon certain criteria in 21 CFR 114 and 21 CFR 113, acidified and low acid foods may be adulterated within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)) in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.
During the inspection, our investigators documented deviations from the Act and the above mentioned regulations relating to the processing of Mango Butter. The deviations cause your acidified food products to be adulterated and in violation of the Section 402(a)(4) of the Act, in that your Mango Butter has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the Acidified Food regulations on the Internet through links on the FDA’s home page at http://www.fda.gov.
The significant violations we found at your acidified food processing facility are as follows:
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 levels, 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 has failed to file a scheduled process for your mango butter product.
According to your written response to the FDA 483, dated June 21, 2012, you are working with a process authority in order to adequately file a process for your mango butter product. However, your firm is responsible for determining which regulations apply to all products that you manufacture, including whether any of these products are considered to be acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR Parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including process filing for those products that are determined to be acidified foods.
2. You must exercise sufficient control, including frequent testing and recording of results, to insure the equilibrium pH values are not higher than 4.6, as required by 21 CFR 114.80(a)(2). However, our investigator determined you are not monitoring the final equilibrium pH for your mango butter product. You were observed measuring the pH of your mango butter during the in-process hot fill manufacturing step rather than waiting a sufficient period of time for the final equilibrium pH. On multiple occasions, your mango butter pH monitoring records indicate that your in-process pH exceeded 4.6; however, you failed to retest once the product’s final equilibrium pH was achieved. In addition, you continued to ship the mango butter products with in-process pH values higher than 4.6.
According to your written response to the FDA 483, dated June 21, 2012, you have voluntarily removed all mango butter product from store shelves and ceased manufacturing mango butter until you consult with a process authority. In addition, you state that you will conduct finished product equilibrium pH testing (b)(4) hours after hot filling once production has started. We will verify the adequacy of your corrections during our next inspection.
3. You must ensure each container is marked with an identifying code specifying the establishment where the product was packed, the product contained therein, the year, date, and period during which it was packed, as required by 21 CFR 114.80(b). However, our investigators observed containers of your mango butter product without an identifying code.
The above violations are not meant to be an all-inclusive list of deficiencies at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Acidified Foods Regulations (21 CFR 114 & 108).
You should take prompt action to correct the violations cited in this letter and to establish and implement procedures which will prevent them from occurring in the future. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice. The Act authorizes actions such as injunctions against manufacturers and distributors of illegal products, the seizure of such products, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit along with other possible legal actions.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If you cannot complete all corrections before 15 days, we expect an explanation for your delay and commitment to a time frame within which you will complete the remaining corrections.
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 non-compliance 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). For a domestic facility, 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 non-compliance 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 directed to Lawton Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration
cc (via email):
Lori K. Nagatoshi
Acting Program Manager
Food and Drug Branch
Hawaii Department of Health