Inspections, Compliance, Enforcement, and Criminal Investigations
Mirrotek International, LLC 2/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4908
February 9, 2012
VIA UPS OVERNIGHT
Mr Joseph Bezborodko, President
Mirrotek International, LLC
90 Dayton Ave Suite 1F
Passaic NJ 07055-7014
File No.: 12-NWJ-11
Dear Mr. Bezborodko:
An inspection of your facility located at 90 Dayton Ave, Suite 1F, Passaic, NJ was conducted by an investigator from the US Food and Drug Administration (FDA) on September 27, 28, & 30, 2011. This inspection verified that your firm manufactures and distributes food products, specifically acidified food products.
As a manufacturer of acidified foods, 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 food products. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control, (21 CFR 108), and Part 114, Acidified Foods (21 CFR 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 acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements of 21 CFR 114. In addition, based upon certain criteria in Part 114, acidified 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 unsanitary conditions whereby they may have become contaminated with fifth, or whereby they may have been rendered injurious to health. Your Firm's failure to fulfill the requirements of 21 CFR 108.25 and mandatory requirements of 21 CFR 114 renders your Iron Chef™ General Tso's Sauce and Glaze (Net Wt. 15 oz) and Sesame Garlic Sauce and Glaze (Net Wt 10 Pounds) adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and the Acidified Food regulations through links on FDA's home page at www.fda.gov.
The significant violations found at your acidified food processing facility are as follows:
1. Your firm failed to register information with the FDA including: the name, place of business, and the location of the processing establishment within 10 days after engaging in the manufacture, processing, and packaging of acidified foods as required by 21 CFR 108.25(c)(1). Specifically, your firm has been manufacturing two acidified products, Iron Chef™ General Tso's Sauce and Glaze and Sesame Garlic Sauce and Glaze, since January 2011 without registering the aforementioned information with the FDA.
2. Your firm failed to provide to FDA information on the scheduled processes for each acidified food in each container size as required by 21 CFR 108.25(c)(2). Specifically, you have not filed scheduled processes with the FDA for your Iron Chef™ General Tso's Sauce (Net wt. 15 oz) and Sesame Garlic Sauce and Glaze (Net Wt 10 Pounds).
3. Personnel involved in acidification, pH control, heat treatment and critical factors were not under the operating supervision of a person who has attended, and satisfactorily completed, a school approved by the Commissioner for giving instruction in food-handling techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls and critical factors in acidification as required by 21 CFR 108.25(1). Specifically, none of your personnel has attended and satisfactorily completed a school approved by the Commissioner.
4. Your firm failed to examine containers often enough to ensure that the containers suitably protect food from leakage and contamination as required by 21 CFR 114.80(a)(4). Specifically, your firm is not documenting the visual examination of containers that is purportedly conducted. Furthermore, you do not have a written procedure outlining the frequency of the examination or the manner in which the examination is conducted.
5. Your firm failed to prepare and maintain current procedures for recalling products that may be injurious to health; identifying, collecting, warehousing, and controlling products; determining the effectiveness of recalls; notifying FDA of any recalls, and implementing recall programs as required by 21 CFR 108.25(e). Specifically, your firm does not have a written recall procedure.
Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.fda.gov/Food/FoodSafety/Product-Specificlnformation/Acidifiedlow-AcidCannedFoods/
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. 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 assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice. including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter. please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason tor the delay and the time within which you will complete the correction.
Your response should be addressed to U.S. Food and Drug Administration. 10 Waterview Boulevard. 3th Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilia, Compliance Officer.
New Jersey District