Inspections, Compliance, Enforcement, and Criminal Investigations
Mystical One LLC 10/5/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New York District
158-15 Liberty Avenue
Jamaica, NY 11433
October 5, 2009
WARNING LETTER NYK-DO 2009-20
VIA FEDERAL EXPRESS
Hank J. Hagen, President/CEO
Mystical One LLC
10621 Guy R. Brewer Blvd.
Jamaica, NY 11433
Dear Mr. Hagen:
We inspected your juice processing facility located at 10621 Guy R. Brewer Blvd., Jamaica, NY on August 10-13, 2009. 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) and the Current Good Manufacturing Practice regulation for food, Title 21 Code of Federal Regulations, Part 110 (21 CFR 110). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies 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 USC § 342(a)(4). Additionally, failure of a food facility to comply with the requirements of the Current Good Manufacturing Practice regulation, 21 CFR 100, 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 milk and carrot juice beverage (ie. your "Fresh Carrot Juice" product) 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 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, 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 product that you process, and 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 Parts 120.7(a) and 120.8(a). However, your firm does not have a written hazard analysis or a written HACCP plan for your milk and carrot juice beverage (i.e. your "Fresh Carrot Juice" product) or any other 100% vegetable or fruit juice ingredients or juice drinks that you produce.
Furthermore, you must include in your HACCP analysis and 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 l20.24(a)].
Moreover, as a result of several instances of botulism poisoning from refrigerated carrot juice, FDA issued guidance in June 2007 recommending 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 in distribution by 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 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:
Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments, as evidenced by: A wooden utensil used to mix raw ingredients for ready-to drink milk and carrot juice beverage (i,e. your "Fresh Carrot Juice" product) was observed to be non-smooth, porous and not easily cleanable. [21 CFR Parts 120.6(a)(2) and 120.6(b), and 21 CFR Part 1I0.35(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: I) An employee was observed walking from the juice production room to the outside of the firm and back to the juice production room wearing the same gloves and apron. Your Ready-to-drink-milk and carrot juice beverage (i.e. your "Fresh Carrot Juice" product) was in production at the time of this observation; 2) Bags of carrots and sugar used to produce ready-to-drink carrot juice were stored directly on the floor in the hallway below hanging employee personal and protective clothing; and 3) A plastic lid was observed to be cleaned using soapy water in one compartment of the two compartment sink. Peeled carrots were stored in the adjacent compartment of this sink. Soapy water was observed to spray from the plastic lid directly onto the peeled carrots. The carrots are rinsed in this sink prior to juicing operations in the production of ready-to-drink milk and carrot juice beverage that is not thermally processed. [21 CFR Parts 120.6(a)(3) and 120.6(b), and 21 CFR Part 110.80(b)(5)]
Maintenance of hand washing, hand sanitizing, and toilet facilities, as evidenced by: The hand washing sink located in the employee restroom was not equipped with hand wash soap on August 10, 2009 while ready-to-drink milk and carrot juice beverage was in production. The hand wash sink in the processing room was not equipped with hand wash soap or paper towels during this inspection. [21 CFR Parts 120.6(a)(4) and 120.6(b)].
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/Proper labeling, storage, and use of toxic compounds, as evidenced by: 1) A large bottle with an attached spray nozzle containing insect spray was observed to be stored on the floor directly next to a bag of sugar in the labeling room. This sugar is used in the production of various juices; and 2) A spray bottle containing pine cleaner was observed to be stored directly next to an uncovered container of cinnamon on the bottom shelf of the preparation table in the juice production room. This cinnamon is used as a spice in various juices. [21 CFR Parts 120.6(a)(5), 120.6(a)(6), and 120.6(b), and 21 CFR Part 110.35(b)(2)]
Exclusion of pests from the food plant, as evidenced by: 1) Numerous flies were observed throughout the juice processing room and bottle labeling room throughout the inspection; 2) On August 10, 2009 the front door of your facility was observed to be left open and the back door leading to your juice production room was open, providing no screening between the outside and your production room; and 3) Garbage is stored in plastic bags on the ground outside the back screen door that leads directly to your juice production room. The grounds behind your back screen door that lead to your juice production room contain tall weeds and grass. [21 CFR Parts 120.6(a)(8) and 120.6(b), and 21 CFR Parts 110.35(c), 110.20(a)(1), and 110.20(b)(7)]
In addition to correcting your firm's juice HACCP and Good Manufacturing Practice violations, we recommend that you review the labeling of your "Fresh Carrot Juice" as it fails to reflect the product's true statement of identity.
We have reviewed your September 28, 2009, response to the Form FDA-483, however we determined that your firm's corrective actions as described did not adequately address the significant violations and will have to be verified during our next inspection.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the juice RACCP 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.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things that 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.
Camille D. Monde
Acting District Director
New York District