Inspections, Compliance, Enforcement, and Criminal Investigations
Kohinoor Foods, Inc. 9/15/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5703
VIA FED EX
Mr. Satnam Arora, President
Kohinoor Foods, Inc.
201, Vipps Centre
Greater Kailish - 11
New Delhi, India - 110048
Dear Mr. Arora:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 9198 Red Branch Road, Suite H, Columbia, Maryland on April 29 and 30 and May 1, 4, 8,26 - 29, 2009. The inspection determined that your firm is a food distributor and repacker as your firm receives Turkish Apricots, Almonds and Whole Moong, repackages these food products and distributes them in interstate commerce. During the inspection, our investigators collected label samples from your repackaged Turkish Apricots, Almonds and Whole Moong products. Based on our review of your product labels, your Turkish Apricots, Almonds and Whole Moong products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act can be found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
Your firm's labeling violations include:
1. Your Turkish Apricot, Almond, and Whole Moong products are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] in that there is no declaration of nutrition facts information as required in 21 CFR 101.9. For example:
i. The serving declaration is not expressed in common household measure [21 CFR 101.9(b)(5)]. The serving size must be determined based on the reference amount customarily consumed (RACC) [21 CFR 101. 12(b)].
ii. A statement of caloric content per serving [21 CFR 101.9(c)(1)]. A statement of caloric content derived from total fat in a serving [21 CFR 101.9(c)(1)(ii).
iii. A statement of the number of grams of total fat per serving [21 CFR 101.9(c)(2)]. A statement of the number of grams of saturated fact in a serving [21 CFR 101.9(c)(2)(i)]. A statement of the number of grams of trans fat in a serving [21 CFR 101.9(c)(2)(ii)].
iv. A statement of the cholesterol content in a serving expressed in milligram increments [21 CFR 101.9(c)(3)].
v. A statement of the number of milligrams of sodium in a specified serving [21 CFR 101.9(c)(4)].
vi. A statement of the number of grams of total carbohydrate in a serving [21 CFR 101.9(c)(6)].
vii. A statement of the number of grams of total dietary fiber in a serving [21 CFR 101.9(c)(6)(i)].
viii. A statement of the number of grams of sugars in a serving [21 CFR 101.9(c)(6)(ii)].
2. Your Turkish Apricot, Almond, and Whole Moong products are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the labels for these products fail to declare the net weight in terms of pounds and ounces as required by 21 CFR 101.1 05(b)(2). These product labels also fail to list the net weight amount preceded by the term "net weight" or "net content" as required by 21 CFR 101.1050)(3). In addition the net quantity of contents declaration is not located within the bottom 30 percent of the area of the label panel in lines generally parallel to the base as required by 21 CFR 101.105(f).
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies on your labels. Other label violations can subject the food to legal action. It is your responsibility to assure that all of your products are labeled in compliance with all applicable statues enforced by FDA.
Furthermore, our investigator issued a Form FDA-483, Inspectional Observations, at the end of the inspection to Mr. Latiwala, the Branch Manager at your Columbia, Maryland location, and discussed these observations with him. The observations listed on the FDA-483 pertain to requirements for current good manufacturing practice (CGMP) in the manufacturing, packing, or holding of human food (21 CFR 110). Your firm's ability to comply with these requirements, specifically those discussed during the inspection, will be observed during a future inspection. You should 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 such as copies of the new labels for the products that your firm repacks, or other useful information 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: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.