Lebanese Arak Corp 9/28/11
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
September 22, 2011 WL 56-11
Garo Kurkjian, President
Lebanese Arak Corp
724 Thompson Ave
Glendale, CA 91201
Dear Mr. Kurkjian:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Lebanese Arak Corp located at 724 Thompson Ave, Glendale, CA 91201, on 04/25/11-4/29/11. The inspection revealed serious violations of 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 lemon and lime 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.
Also, as further discussed below, several of your products are misbranded within the meaning of Section 403 of the Act.
You may find the Act, FDA’s labeling and juice HACCP regulations, 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:
- 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, as required by 21 CFR 120.24(a). However, your critical limit of “pH less than 4.6” at the blending critical control point (CCP) in your Juice Products HACCP plan does not ensure control of pathogenic microorganisms, including Listeria monocytogenes, in your 100% lemon and lime juices.
We received your written response dated May 10, 2011. In your response, you indicate that you consulted with an industry expert and determined a pH level of 4.6 is acceptable. Your response is inadequate because you do not have scientific data or evidence that the current critical limit will consistently produce a 5 log reduction of the pertinent microorganism. We reviewed the validation study performed by (b)(4). The study used USP 24 <51> - Antimicrobial Effectiveness Test. USP 24 <51> is an effectiveness test used for pharmaceutical products and is not intended to validate a five log reduction process. In addition, the study data provided during the inspection does not identify the test parameters such as sample pH, total acidity, preservative concentrations, time or temperature that may be critical factors of the process. The conclusion stated by (b)(4) is that “*** A preservative is considered effective against bacteria if at least a 1 log reduction of bacteria occurs from the initial count at 14 days and there is no increase from 14 days to 28 days. Preservative is effective against all test organisms based on USP <51> procedure.” Our review finds that the study does not demonstrate a 5 log reduction of bacterial pathogens. The study also did not cover Listeria monocytogenes, the pertinent microorganism in reconstituted juices.
- Your HACCP plan must, at a minimum, list the critical control points for each identified food hazard that is reasonably likely to occur, as required by 21 CFR 120.8(b)(2). However, your HACCP plan for consumer labeled 100% lemon and lime juices does not list a critical control point for controlling the food hazard of added sulfites. Your firm identified sulfites as a significant hazard reasonably likely to occur but did not address the lack of a critical control point in your HACCP plan, specifically at the labeling step, to control the hazard of added sulfites.
In you response you state “***we have a specific area that is designated in our document to control this allergen in our blending process.” Your response is inadequate because it does not address the lack of a CCP in your HACCP plan at the labeling step to control the hazard of added sulfites.
3. You must have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during, and after processing, as required by 21 CFR 120.6(a), and you must adequately monitor conditions and practices during processing with sufficient frequency to ensure conformance with those conditions, as well as the current good manufacturing practice requirements in 21 CFR Part 110, as required by 21 CFR 120.6(b). However, your firm did not the monitor condition and cleanliness of food contact surfaces; prevention of cross contamination from insanitary objects to food; and labeling, storage and use of toxic compounds, with sufficient frequency as evidenced by the following observed at your facility on 04/27-28/11:
(a) Condition and cleanliness of food contact surfaces [21 CFR 120.6(a)(2)]
- Water supply hoses and pump connection hoses used in juice production were observed on the production room floor and/or held in unclean buckets were used to produce lemon juice lot #4203 without first being cleaned and sanitized.
- The utensils and buckets used in the manufacture of your 100% juice products are not cleaned and sanitized prior to use. These items are only rinsed with water.
- A bucket used to transfer sodium benzoate and potassium sorbate was stored under a work station on 4/27/11. The container contained a visible build-up of white, powdery residue. The container was used to measure raw materials and was returned to the workstation shelf without cleaning. The container was used again during manufacture of 100% lemon juice on 4/28/11.
- A glass jar was used to transfer lemon oil to the blending tank during production of lemon blend on 4/27/11. The container was placed on a shelf without cleaning and covered with a wooden board. The container was still on the shelf as such on 4/28/11.
(b) Prevention of cross contamination from insanitary objects [21 CFR 120.6(a)(3)]
- Buckets placed in standing water on the floor of your production facility were used to transfer juice from the filler back into the blending tank. Drops of water from the side of the bucket were observed falling into the tank during juice production.
- Two employees were observed rinsing their hands without use of soap in the three-compartment sink where utensils are also rinsed. The employee’s hands were observed in contact with water that was added to juice concentrate as well as in rinsing pitchers and buckets used to transfer juice product to and from the blending tank.
- Employees were manufacturing juice products wearing street clothes without protective outer garments.
- Employees with uncovered facial hair were observed working directly over juice concentrate and in-process juice in the blending tank.
- Employees with hairy arms were observed not wearing gloves or arm covers during processing on 4/27/11. Employees were also observed with unprotected hands/arms during transfer of juice to the blending tank and during filling of bottles that had not been completely filled by the filler on 4/28/11.
(c) Protection of food, food packaging material, and food contact surfaces from adulteration [21 CFR 120.6(a)(5)]
- On 4/27/11, the intake vent of the table motor was observed visibly soiled with an accumulation of dust. The vent cover was directly over open bottles on their way to the filler. The motor housing was observed to vibrate while the open bottles were passing underneath.
(d) Labeling, storage and use of toxic compounds [21 CFR 120.6(a)(6)]
- On 4/27/11 and 4/28/11, the concentration of chlorine based sanitizer effluent from the filling machine was measured at above 200 ppm.
Your response is inadequate because it did not address many of the sanitation deficiencies. Your response indicated that you have taken the actions listed below; however, this is inadequate because further documentation is needed:
- You have placed an order for hoses that will dangle from the ceiling and not touch the ground. Your response is inadequate because you have not provided receipts or evidence of the purchase of the new hoses.
- You have implemented outer garments that are to be worn by anyone working in the facility. Your response is inadequate because you have not provided details or documentation of this correction.
- You placed signs in various locations and in the bathrooms directing employees to wash their hands. Your response is inadequate because you have not provided documentation of retraining employees on hand washing or documentation of enhanced monitoring of employees to ensure that they are washing their hands as necessary.
- You will be implementing a new Clean in Place (CIP) system, revising your cleaning and sanitizing procedures, and changing the chemicals used. You also provided a blank record titled “SANITATION PROCESS” in your response. However, you have not provided evidence of correction such as current sanitation monitoring records indicating proper sanitizer concentrations.
1. Your “Sadaf Natural Lemon Juice” and “Golchin Lime Juice” products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)], which states that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular.
Your “Sadaf Natural Lemon Juice” product is misbranded because the label uses the term “natural” in a manner that is false and misleading FDA considers use of the term “natural” on a food label to be truthful and non-misleading only when nothing artificial or synthetic has been included in, or has been added to, a food that would not normally be expected to be there [58 FR 2302, 2407, January 6, 1993; see 21 CFR 101.22(a)]. Because your product contains sodium benzoate and sodium bisulfite, which are chemical preservatives, the use of the claim “natural” on the product label is false and misleading.
2. Your Sadaf Apple Cider Vinegar is misbranded within the meaning of 403(q) of the Act [21 CFR U.S.C. 343(q)] in that your product’s nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
- The serving size declaration is incorrect. Your product would be considered a major condiment. Based on 21 CFR 101.12, the proper serving size declaration would be, “1 tbsp (__g); 1 tbsp (15mL).
- The Trans Fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
The above violations are not intended to be an all-inclusive list of violations. It is your responsibility to ensure that all of your products are in compliance with the Act and FDA’s 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 without further notice, such as seizure and/or injunction.
We also note the following comments about your product labels:
- Your “Sadaf Natural Lemon Juice” and “Golchin Lime Juice” fail to declare the term “From Concentrate” in type size no less that one-half the height of the letters in the name of the juice, as required by 21 CFR 102.33(g)(1).
- Your “Golchin Lime Juice” fails to declare the word “Blend” in the same type size as the rest of the statement of identity [21 CFR 101.3(d)].
- Your Golchin Lime Juice label contains foreign characters. In accordance with 21 CFR 101.15(c)(2), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must also appear in the foreign language.
You should 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 revised HACCP plans, revised sanitation standard operating procedures, recent monitoring records, training records, and revised labeling. 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:
Director Compliance Branch
Los Angeles District
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.
Alonza E. Cruse
Los Angeles District
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. box 997435
Sacramento, CA 95899-7435