Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215
August 15, 2011
RETURN RECEIPT REQUESTED
Mr. Theodore Pavlos, President
SCT Corporation, dba Jeppi Nut Company
9 West Aylesbury Road, Suite M-p
Timonium, MD 21093
Dear Mr. Pavlos:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 9 West Aylesbury Road, Suite M-p, Lutherville-Timonium, MD 21093 from April 26, 2011 to May 10, 2011. You are a manufacturer, packager, and repacker of a variety of products including peanuts, popcorn, and nut mixes. We reviewed your labels for conformance to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and the implementing regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Our review found that the labeling of these products causes your foods to be misbranded within the meaning of section 403(q), and 403(i) of the Act, 21 U.S.C. §§ 343(w), and 343(i). You can find the Act and FDA regulations through links at FDA's Internet home page at http://www.fda.gov1.
1. Your Jeppi Nut Company Salted Roasted Peanuts in the shell (NET WT. 6 OZ (170g)), JEPPI GOURMET POPCORN (NET WT. 3LB (48 OZ)) and JEPPI Nut Company Pistachios (NET WT. 2.5 OZ (70.9G)) are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the product label fails to declare trans fat on the nutrition facts information panel in accordance with 21 CFR 101.9(c)(2)(ii).
2. Your firm uses the same label for both your red and natural pistachio products, however, the ingredients statement on the label is for both your Natural and Red Pistachio Products, (2.50z package). The regulations do not allow for such an ingredient statement.
You must ensure that the label of each product lists all ingredients that the product contains, as required by section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and 21 CFR 101.4(a)(l).
In addition, FDA regulations does allow for dual ingredient statement; however, your label is not in accordance with 21 CFR 101.100(a)(1) or section 505.100 of FDA's Compliance Policy Guide for such labeling.
The above label violations represent a snap shot of misbranded product labels not declaring trans fat nutrient information.
Our investigator issued you the Form FDA 483, Inspectional Observations, at the conclusion of the inspection that addressed effective measures not being taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests.
We acknowledge your response letter sent to the Baltimore District Office dated June 7, 2011 addressing your proposed corrective actions for the labeling violations. However, your response was not signed by you or your representative and it does not show what immediate corrective action you will implement. We therefore have no assurance that you have committed your facility to correcting the labeling violations and are not distributing misbranded products.
The above is not intended to be an all-inclusive list of violations. As a processor of human foods, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the Act and all applicable regulations. You should take prompt action to correct the violations described in this letter and establish and implement procedures which will prevent them from occurring in the future. Failure to take appropriate corrective action may subject your firm and products to further actions. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating in violation of the Act.
In addition we offer the following comment about your product labels:
Your "Salted Roasted Peanuts" and "Pistachios" products both contain intervening material on their information panels. Both state "Maryland's Peanut King Since 1884" between the ingredient statement and name/place of business. Furthermore, the "May Contains Peanuts Traces" statement on the "Pistachios" product is also intervening in accordance with 21 CFR 101.2(e).
You should notify this office, in writing, describing the corrective actions that you will take to bring your firm into compliance within fifteen (15) working days of receiving this letter. Your response should include each corrective action that you have or will take to correct these violations, and in particular, what methods and controls you will implement to prevent their recurrence. Please include copies of any documentation that demonstrates the corrections have been implemented.
If corrective action cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed.
If you have questions regarding any issues in this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at (410) 779-5437 or email@example.com.