|Company:||Cut Fruit Express, Inc.|
|Subject:||CGMP for Foods/HACCP/Adulterated|
|Issuer:||Minneapolis District Office|
|Issued:||March 31, 2010||Closed:||Feb. 8, 2011|
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7194
FAX: (612) 334-4142
March 31, 2010
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 13
Cut Fruit Express, Inc.
11585 Courthouse Boulevard
Inver Grove Heights, Minnesota 55077
Dear Mr. Baxter:
Investigators from the Food and Drug Administration (FDA) inspected your facility located at 11585 Courthouse Boulevard, Inver Grove Heights, Minnesota, on December 15-18, 2009. We found you are in serious violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that you violate the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 and the Current Good Manufacturing Practices regulation for food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 and 110). Also, your products are misbranded within the food labeling warning, notice and safe handling statements contained within Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Together, these deviations cause your 100% juices (orange, grapefruit) to be in violation of sections 402(a)(4) and 403(h)(3)(B) of the Act. You can find this Act and the juice HACCP regulations through links on FDA's home page at www.fda.gov.
The observations of concern to us are 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, you do not have HACCP plans for your 100% orange and 100% grapefruit juices that are manufactured by your firm. Furthermore, your firm does not have a written Hazard Analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards.
2. You must achieve a five-log pathogen reduction through treatments that are applied directly to the juices, or, as with citrus juice processors, such as yourself, apply a treatment to fruit surfaces that achieves a 5-log reduction on the surfaces of the fruits. However, you use a surface treatment, (b)(4) , to treat the fruit prior to juice extraction for which we are unable to find any documentation in the published literature to substantiate its efficacy in achieving the 5-log reduction on the surfaces of the fruits. Moreover, you have not provided scientific documentation of any other types of studies, e.g., private studies, supporting the efficacy of this treatment for achieving the required pathogen reduction in your fresh squeezed juices, to comply with 21 CFR 120.12(a)(5) and 120.24(b).
In addition, your firm should not be labeling your 100% citrus juice products with the warning statement described in 21 CFR 101.17(g)(2)(ii), since these products are subject to the juice HACCP regulation.
3. You must analyze your finished juice products for biotype I Escherichia coli when you rely on a treatment that does not come into direct contact with all parts of the juices, to comply with 21 CFR 120.25. However, you do not analyze your finished juice products for biotype I Escherichia coli.
4. You must have sanitation standard operating procedure (SSOP) records that, at a minimum, document monitoring of sanitation conditions and practices during processing and correction of conditions and practices that conform to appropriate provisions in 21 CFR 120.6(c) and 21 CFR 120.12(a)(1). However, your firm does not maintain SSOP records for the following:
a. 21 CFR 120.6(a)(5) - Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants: You do not have sanitation monitoring records that document the protection of food, food packaging material and food contact surfaces.
b. 21 CFR 120.6(a)(7) - Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces: You do not have sanitation monitoring records that document the control of employee health conditions.
5. You must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice regulations, to comply with 21 CFR 120.6(b). However, your firm did not monitor condition and cleanliness of food contact surfaces, maintenance of hand washing, hand sanitizing, and toilet facilities, and proper labeling, storage and use of toxic compounds with sufficient frequency, as evidenced by:
a. 21 CFR 120.6(a)(2) - Condition and cleanliness of food contact surfaces: On December 15, 2009, your (b)(4) juice extractor had extensive product buildup in the upper hopper. The extractor would not be cleaned and sanitized again prior to use.
b. 21 CFR 120.6(a)(4) - Maintenance of hand washing facilities, hand sanitizing, and toilet facilities: On December 15, 2009, in your retail vegetable room, the employee hand sink did not have hot water.
c. 21 CFR 120.6(a)(6) - Proper labeling, storage, and use of toxic compounds: On December 16,2009, in the chemical compound cage, the barrel of sodium hypochlorite did not have any labeling.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and injunction. Your reply should be directed to Compliance Officer Rebecca L. Caulfield at the address indicated on the letterhead.
W. Charles Becoat