Inspections, Compliance, Enforcement, and Criminal Investigations
Country Fresh Orlando, LLC 10/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|555 Winderley Place, Ste. 200|
Maitland, FL 32751
Telephone: (407) 475-4700
FAX: (407) 475-4769
Return Receipt Requested
October 9, 2012
Country Fresh Inc.
701 Jet Stream Drive
Orlando, Fl 32824
Dear Mr. Escobell:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 701 Jet Stream Drive, Orlando, FL on May 21 & 22, 2012. During the inspection our investigator collected labels of your Fresh Sliced Banana with Strawberry Yogurt Parfait, Strawberry & Blueberry Yogurt Parfait, Fresh Fruit & Yogurt Parfait and Brushetta products. Our review of those labels found that your products are misbranded within the meaning of section 403 [21 U.S.C.§ 343] of the Food Drug and Cosmetic Act (The Act) and under Title 21 of the Code of Federal Regulations (21 CFR 101). You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
Your Fresh Sliced Banana with Strawberry Yogurt Parfait, Strawberry & Blueberry Yogurt Parfait, Fresh Fruit & Yogurt Parfait and Brushetta products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that they fail to bear a nutrition facts panel as required by CFR 101.9 and the products are not subject to an exemption.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
During our label review we also noted these additional observations:
• The statement of identity and ingredient statement on the principal display panel (PDP) sticker for your Strawberry and Blueberry Yogurt Parfait product are inconsistent.
• The name and place of business on your product labels do not include a street address (21 CFR 101.5]. The street address may be omitted if it is shown in a current city directory or telephone directory.
• The term "Strwbry" is spelled incorrectly in the ingredient statement for your Fresh Sliced Banana with Strawberry Yogurt Parfait product.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including explanation of how you plan to prevent these violations or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your response to the U.S. Food and Drug Administration, Florida District Office, Attention: Carla A. Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.
Emma R. Singleton
Director, Florida District
Close Out Letter