|Company:||Food With Care Inc.|
|Issuer:||Florida District Office|
|Issued:||June 20, 2005||Closed:||
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
June 20, 2005
Jonathan Fran Glancy
President and CEO
Food With Care Inc.
6995 Venture Circle
Orlando, FL 32807
Dear Mr. Glancy:
On January 27, 2005 to February 2, 2005, we inspected your seafood processing facility, located at the above address. We observed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and the Food Labeling Regulations, Title 21 CFR Part 101.
In accordance with 21 CFR 123.6(g), failure of a seafood processor to have and implement a HACCP plan that complies with that section or otherwise operate in accordance with the requirements of 21 CFR Part 123, renders fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). Accordingly your cooked shrimp-containing seafood meals are adulterated, in that those products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
We observed the following deviation from the seafood HACCP regulations:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for shrimp products to control the food safety hazard of food additives, such as sulfiting agents.
Our review of the labeling on your "Baked Salmon" dinner reveals that the labeling lacks information required under the Act and FDA regulations. The label review revealed the following deviations:
2. The product is misbranded within the meaning of section 403(q)(1) of the Act in that the label fails to bear nutrition labeling as required by 21 CFR 101.9 and the product is not exempt from this requirement.
3. The product is misbranded within the meaning of section 403(i)(2) of the Act in that it is fabricated from two or more ingredients but the label fails to bear the common or usual name, in descending order of predominance, of ingredients in the product, as required by 21 CFR 101.4 (a)(1).
4. The product is misbranded within the meaning of section 403(e)(2) of the Act in that its label fails to bear a net quantity of contents statement, as required by 21 CFR 101.105.
The above violations are not meant to be an all-inclusive list of violations at your firm. You are responsible for ensuring that your processing facility operates in compliance with the Act and FDA regulations. 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.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as your hazard analysis and HACCP plans, revised product labels or other useful information that will assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Shari H. Shambaugh, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751
If you have questions regarding any issue in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District