Inspections, Compliance, Enforcement, and Criminal Investigations
First Season, Inc 1/26/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
January 26, 2009
RETURN RECEIPT REQUESTED
Mr. Denis P. Ryan
First Season, Inc.
2254 North Elston Avenue
Chicago, IL 60614
Dear Mr. Ryan:
The Food and Drug Administration inspected your firm, located at 2254 N. Elston Avenue, Chicago, IL, between September 24 and September 29, 2008. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice 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 orange juice and strawberry banana juice products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been, rendered injurious to health. You may find the Act, the Juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at http://www.fda.gov./
Your significant violations were as follows:
1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HACCP plan for your Orange Juice and Strawberry Banana Juice to control the food safety hazard of pathogens.
In addition, your HACCP plan for these products must included control measures that will consistently produce, at a minimum, a 5 log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism, to comply with 21 CFR 120.24(a).
2. You must have sanitation control records that document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation control records for the condition and cleanliness of food contact surfaces; the prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces; the protection of food, food packaging materials, and food contact surfaces from adulteration with contaminants; proper labeling, storage, and use of toxic compounds.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation (21 CFR Part I 10). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable 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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response documentation such as copies of your revised juice HACCP plans; process controls for 5 log reduction of pertinent microorganisms; sanitation monitoring records; related sanitation corrective actions; or other useful information that would 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: Richard Harrison, Compliance Branch Director, at the address above. If you have any questions regarding any issues in this letter, please contact Mr. Harrison at 312-546-4220.
Scott J. Maclntire