Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Avenue
Jamaica, NY 11433
October 28, 2009
WARNING LETTER NYK-DO 2010-02
VIA FEDERAL EXPRESS
Winston A. Fearson
Juices International, Inc.
1142 Nostrand Avenue
Brooklyn, NY 11225
Dear Mr. Fearson:
We inspected your juice processing facility on July 27-31, 2009. We found 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 Part 120) and the Current Good Manufacturing Practice regulation for food, Title 21 Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR Part 120.9, failure of a processor to have and implement a HACCP plan which complies with the requirements of 21 CFR Part 120 renders the juice products adulterated within the meaning of Section402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC § 342(a)(4). Additionally, failure of a food facility to comply with the requirements of the Current Good Manufacturing Practice regulation in 21 CFR Part 110 renders food products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC § 342(a)(4). Accordingly, your juice products, including your carrot juice products and any and all 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 because 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, the Juice HACCP Hazards and Controls Guidance, and the Current Good Manufacturing Practice regulations for food in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. You must develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice you process to comply with 21 CFR Part 120.7(a). You must have and implement a written HACCP plan whenever that hazard analysis reveals one or more food safety hazards that are reasonably likely to occur to comply with 21 CFR Part 120.8(a). However, your firm does not have a written hazard analysis or a written HACCP plan for your fresh 100% carrot juice which you manufacture for use in the following beverages: "Carrot Ginger Drink", "Double Trouble Carrot Punch", "Beet Carrot Juice Drink", and "Carrot Juice Drink" to control the food safety hazard of pathogens, particularly Clostridium botulinum.
Furthermore, you must include in your HACCP plan control measures that will consistently produce, at a minimum a 5 log reduction of the pertinent microorganism for a 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). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice" [21 CFR Part 120.24(a)].
Moreover, as a result of several instances of botulism poisoning from refrigerated carrot juice, FDA recommends that a process be applied that will ensure that Clostridium botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated after distribution to the consumer.
2. You must have and implement a Sanitation Standard Operating Procedure (SSOP) that addresses the eight critical points of sanitation conditions and practices before, during and after processing [21 CFR Part 120.6(a)]. You must adequately monitor sanitation conditions and practices with sufficient frequency to ensure conformance with Current Good Manufacturing Practice regulations to comply with 21 CFR Part 120.6(b). Additionally, all of your juice and juice products must comply with 21 CFR Part 110. However, your firm failed to do so as specified below:
Safety of water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice, as evidenced by: Water used to cool bottles of juice immediately following thermal processing is not chlorinated to ensure that it does not present the risk of post process contamination of the juice products manufactured. Your firm's manufacturing procedure includes the cooling of finished product in the ware-wash sink, through running cold water [21 CFR Parts 120.6(a)(1) and (b)].
Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, as evidenced by: Food processing equipment, specifically sieves/strainers and a juicing machine, were observed with food residue after cleaning; a wooden utensil is used to mix raw ingredients and cannot be adequately cleaned and sanitized due to the porous surface; bulk ingredient mixing buckets and smaller utensils were observed stacked together, upright, after cleaning and without drying, and standing water was observed in the bottom of these containers [21 CFR Parts 120.6(a)(2) and (b), and 21 CFR Part 110.35(a)].
Prevention of cross contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to processed product, as evidenced by: Employees were observed wearing the same protective outer garments and hair covering both inside the production area and outside the plant; cleaning mops were observed stored in the back yard where exposed soil and refuse were observed; an employee was observed moving between the dirt floor in the backyard and the production room while conducting cleaning operations and soil was tracked into the production area; condensate was observed dripping from the walk-in refrigerator condenser into 5 gallon buckets below; raw material Irish Moss was observed in the refrigerator in a container without any covering, adjacent to the refrigeration condenser; and dust and dirt particles were observed hanging from light fixtures and ceiling tiles throughout the production room and directly above the bottle filling area [21 CFR Parts 120(a)(3) and (b), and 21 CFR Part 110.80(b)(5)].
Maintenance of hand washing, hand sanitizing, and toilet facilities, as evidenced by: The employee restroom, located within the production area, does not have any lighting and wash water from the sink was observed to flow through a drain pipe that is directed through the bathroom wall into the production area and then through the floor. This location is adjacent to the storage area for cleaned processing equipment. This waste pipe was observed cut open at the elbow that directs the pipe through the floor and the waste water is visibly exposed to the production room environment [21 CFR Parts 120(a)(4) and (b)].
Exclusion of pests from the food plant, as evidenced by: Several flies were observed in the production room landing on walls, ceilings, and processing equipment. Ants, too numerous to count, were observed crawling on apparent food residue observed at the floor wall junction behind the stove in the production room [21 CFR Parts 120(a)(8) and (b), and 21 CFR Part 110.35(c)].
3. You must hold foods which can support the rapid growth of undesirable microorganisms, particularly those of public health significance, in a manner that prevents the food from becoming adulterated in order to comply with 21 CFR Part 110.80(b)(3). However, you failed to cool and maintain thermally processed carrot juice products, labeled as "KEEP REFRIGERATED" at refrigerated temperatures to prevent the rapid growth of Clostridium botulinum as evidenced by:
On July 29, 2009, we observed your manufacturing process for carrot juice, which was cooled from 203 degrees Fahrenheit to 80 degrees Fahrenheit by 3:30 pm under cold, running water in your three compartment sink. The lot was then placed in a small refrigeration unit located in the front of your facility near the street entrance. At 6:00 pm, the carrot juice was observed stored in the bottom of the two-door refrigeration unit and exhibited temperatures of 80 degrees Fahrenheit. At 10:30 am on July 30, 2009, the temperature of this product was observed at 53 degrees Fahrenheit. As observed, cooling of your firm's carrot juice manufactured on July 29, 2009 completed thermal processing at 3:30 pm on July 29, 2009, exhibited a refrigerated storage temperature of 53 degrees Fahrenheit on July 30, 2009 at 10:30 am - 19 hours after thermal processing was completed. Refrigerated foods should be maintained at or below 45 degrees Fahrenheit.
This letter may not list all the deviations at your facility. You are responsible for ensuring your firm operates in compliance with the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).
You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. Such actions include seizure and injunction. We note that you have received prior information regarding similar deficiencies in an FDA 483 issued to you on November 21, 2007.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, 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: Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have any questions regarding any issues in this letter, please contact Ms. Clark at 716-551-4461, ext. 3168.
Laurence D. Daurio
Acting District Director
New York District