| | |
 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
| | Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
January 13th, 2011 W/L 20-11
Mr. Steven A. Mullen, President
Healthy Choice Island Blends, Inc.
1920 McGarry Street
Los Angeles, CA, 90058
Dear Mr. Mullen:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Healthy Choice Island Blends, Inc, located at 1920 McGarry St, Los Angeles, CA, 90058, on 09/13-28/2010. The inspection revealed that you are manufacturing juices, and juice based beverages and you have serious deviations from the juice Hazard Analysis and Critical Control Point (HACCP) regulation, [21, Code of Federal Regulations (CFR), Part 120], and the Current Good Manufacturing Practice regulation for food, [21 CFR, Part 110].
In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of this part, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Food Drug and Cosmetic Act [ 21 U.S.C. § 342(a)(4)]. Accordingly, your juice products, including your apple, carrot, orange, pomegranate, and watermelon juice and any other vegetable or fruit juices, whether sold as 100% juice, or
used as ingredients in the manufacturing of juice beverages containing less than 100% juice, 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
www.fda.gov.
The significant violations documented during the inspection include the following:
1. Your HACCP plan is not specific to each type of juice processed, as required by 21 CFR 120.8(a)(2). Your HACCP plan for “Small Batch Juices” is not specific to the types of 100% juice manufactured by your firm including apple and orange juice from concentrate, and watermelon, cantaloupe, carrot, and celery not from concentrate. Some of these juices are acidic and some, such as carrot and celery juice, are low acid. There are different hazards and controls necessary for the different types of juices. For example, low acid juices have a Clostridium botulinum (C. botulinum) hazard and acidic juices, because of their naturally low pH, do not pose the hazard for C. botulinum toxin formation.
We acknowledge that in response to the FDA-483, you provided copies of new Hazard Analyses and HACCP plans for Low-Acid (including plans for vegetable, melon, and banana/coconut juices), Apple and Apple Blends Juice, and Acidic Juice. The HACCP plans you provided for Low-Acid juices do not include adequate control measures for the hazard of C. botulinum, the pertinent microorganism in low-acid juices. You must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum a 5 log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR Part 120.24(a). For acidic fruit juices, guidance on designating the pertinent microorganism can be found in the Juice HACCP Hazards and Controls Guidance. This guidance can be found at:
Your firm’s open kettle cook at
(b)(4) does not adequately reduce all spores of C. botulinum which could be present in the juice. As a result of several instances of botulism poisoning from refrigerated carrot juice the Agency recommends that a thermal process be applied that will ensure that C. botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept un-refrigerated in distribution or by consumer. This 2007 Guidance for Industry can be found at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Juice/ucm072481.htm. In addition, an adequate thermal process would necessitate a closed cooking system.
2. You must implement the recordkeeping system listed in your HACCP plan, to comply with 21 CFR 120.8(a) and (b)(7). However, your firm did not record monitoring observations at the pasteurization critical control point to control Listeria listed in your HACCP plan for Small Batch Juices. On 09/15/10, the pasteurization CCP monitoring record was not filled out during the manufacturing of cantaloupe and watermelon juice. The record was later filled out incompletely and did not include monitoring data for the start, stop and total pasteurization time. In addition, pasteurization CCP monitoring records for juices manufactured on 07/30/10, 07/25/10, 07/10/10, 07/09/10, 05/24/10, 05/22/10, and 04/21/10 do not include the actual pasteurization temperature values obtained during monitoring, as required by 21 CFR 120.12(b)(4).
You state in your response that personnel will be trained to record actual time and temperature of the product during pasteurization. Your response is inadequate as you have not included any records that the responsible employees have been trained and you do not provide any recent processing records to demonstrate that you have corrected the deficiency.
3. You must adequately monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with current good manufacturing practice requirements in 21 CFR Part 110 that are appropriate both to the plant and to the food being processed, to comply with 21 CFR 120.6(b). However, your firm did not monitor prevention of cross contamination from insanitary objects to food; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; labeling, storage and use of toxic compounds; and exclusion of pests, as evidenced by:
Prevention of cross contamination from insanitary objects to food [21 CFR 120.6(a)(3)]
– Dried seeds, pulp, and build up of orange colored material on surfaces of the orange juicing machine.
– Hose used to dilute juice concentrate to single strength juice lying on the floor with dispensing end touching the floor.
Maintenance of hand washing, hand sanitizing, and toilet facilities [21 CFR 120.6(a)(4)]
– No hot water at the hand washing sink in the bathroom.
– No paper towels at the hand washing sink in the manufacturing area.
Protection of food, food packaging material, and food contact surfaces from adulteration [21 CFR 120.6(a)(5)]
– Use of a knife that had the blade painted and had various areas where the paint was scratched/scraped off to cut watermelon for juice processing.
– Cracked and broken tiles on the wall and floor of the processing room.
– Drain pipe from utensil warewashing sink submerged in clogged floor drain.
Labeling, storage and use of toxic compounds [21 CFR 120.6(a)(6)]
– Use of bleach and water mixture as a sanitizer for food processing equipment without monitoring the concentration of the solution
Exclusion of pests [21 CFR 120.6(a)(8)]
– Fruit flies around the orange juicing machine.
Your response indicates that responsible employees have been trained in sanitation and sanitation monitoring procedures. You also state that a new sanitation monitoring record has been developed. However you have not included any training records for the responsible employees and you do not provide any recent sanitation monitoring records.
4. You must maintain adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 120.6(b) to comply with 21 CFR 120.6(c). However, as evidenced by the observations listed above in item #3, your firm did not maintain adequate sanitation monitoring records for prevention of cross contamination from insanitary objects to food; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; labeling, storage and use of toxic compounds; and exclusion of pests required for the processing of juice products on 09/21-23/10. The records for the subject dates indicate that your firm’s sanitation conditions were acceptable. In addition, these records are inadequate because they do not indicate the time of the activity as required by 21 CFR 120.12(b)(2), and they do not include the signature or initials of the person performing the operation as required by 21 CFR 120.12(b)(3).
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective action, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill
Director Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 858-550-3850 x106.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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