| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone: (510) 337-6700 |
Department of Health and Human ServicesWARNING LETTER
VIA UPS OVERNIGHT
SIGNATURE REQUIRED
September 6, 2011
Mr. Raju C. Boliagala, CEO/President
High Quality Organics
12101 Moya Blvd.,
Reno, Nevada 89506
Dear Mr. Boliagala:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing and repacking facility located at 12101 Moya Blvd., Reno, Nevada, on March 7th through 31st, 2011. FDA's inspection revealed that four of your products; organic ground ginger, organic ground chili pepper, organic sandia chile powder, and organic ground coriander were adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
On March 10th, 2011 your firm initiated a voluntary recall of "tea bag cut ginger" and "organic chili pepper ground natural," after two of your customers found Salmonella in these products. Subsequently, FDA collected samples of your various spice, herb, and botanical products, some of which were associated with your recall of "tea bag cut ginger" and "organic chili pepper ground natural." FDA Laboratory analyses found Salmonella in the following products processed at your facility:
• "Organic Ginger, Ground" Lot# (b)(4)
• "Organic Chili Pepper Ground Naturall" Lot # (b)(4)
• "Organic Sandia Chile Powder" Lot# (b)(4)
• "Organic Coriander, Ground" Lot# (b)(4)
Adulteration
Your products referenced above are adulterated within the meaning of Section 402(a)(1) of the Act, in that the products contain a poisonous or deleterious substance, namely Salmonella, which may render them injurious to health.
On April 21st, 2001, based on FDA's sampling results, your firm initiated a separate voluntary recall of the adulterated lot of "organic coriander, ground."
On April 14th, 2011, your firm responded to the FDA 483 with promised corrective actions and preventive measures. Your promised corrections included an updated procedure for handling product found contaminated with Salmonella, as well as an updated procedure for follow-up environmental sampling. Your written response also included an updated sampling plan for product analysis, QC hold release SOP, Sanitation Standard Operating Procedures (SSOP), and environmental sampling procedure. We continue to have concerns with your corrective action regarding the steam treatment of Salmonella-positive products. Specifically, FDA samples of your "organic coriander, ground" product were found positive for Salmonella after the product had been treated to destroy Salmonella at a steam treatment facility. During our inspection, your firm was unable to determine if the steam treatment process had been validated to ensure your products receive a time and temperature treatment sufficient to eliminate Salmonella. Your response should include documentation that any Salmonella-positive product will undergo a validated steam treatment. In addition, your updated environmental sampling plan includes the weekly sampling of environmental areas inside your facility; however, your plan fails to sample for Salmonella on product contact surfaces. According to your response your firm only tests product contact surfaces after a product has been found contaminated with Salmonella. Lastly, in an emailed letter from your firm, received on April 4, 2011, you state that after an internal investigation, you believe one of your products may have become contaminated with Salmonella after being processed on equipment adjacent to an open rollup door. Your letter further states that you no longer leave the door open during processing and you have taken corrective actions to mitigate any possible exposure of product to potential contamination; however, you do not specify your corrective actions. Please submit documentation outlining the specific corrective actions and their implementation discussed in your April 4, 2011 letter.
Misbranding
Your Organic Chili Pepper Ground Natural and Organic Ground Cayenne Medium Select products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because "Organic Chili Pepper Ground Natural" and "Organic Ground Cayenne Medium Select" are statements of identity that suggest that the products are simply single ingredient spices containing ground chili pepper and ground cayenne pepper, respectively. There is no indication that the products contain another spice, although evidence collected during the inspection indicates that paprika is used in the ground cayenne and chili pepper products. The statement of identities and lack of ingredient statements for these products suggests that the products are single ingredient spices and do not accurately identify the products with an appropriate common or usual name as required by 21 CFR 101.3(b)(2). In addition, under 21 CFR 102.5(a), the common or usual name of a food shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. Therefore, Organic Chili Pepper Ground Natural and Organic Ground Cayenne Medium Select are misleading statements of identities because they suggest that these are single ingredient products.
Your Organic Chili Pepper Ground Natural and Organic Ground Cayenne Medium Select products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients but their labels fail to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1). Specifically, your firm indicated that paprika is added to both products; however your product labels do not bear an ingredient statement, indicating that they are single ingredient products, when they are multi-ingredient products.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with applicable statutes enforced by the FDA. Failure to correct violations of the Act and applicable regulations may result in regulatory action without further notice, such as seizure landlord injunction.
Your Organic Coriander Ground, Organic Ground Cayenne Medium Select, Organic Sandia Chile Powder, Organic Chili Pepper Ground Natural, and Organic Ginger Ground fail to declare the product weight in terms of avoirdupois pound and ounce in accordance with 21 CFR 101.105(b)(1).
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of implementing your corrective actions since your April 14th, 2011, correspondence, including any additional documentation and further specific steps that you have taken to correct the noted violations. 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 violations.
Please send your reply to the Food and Drug Administration, Attention: Darlene Almogela, Director of Compliance Branch, 1431 Harbor Bay Parkway, Alameda, CA. If you have questions regarding any issue in this letter, please contact Brandon Bridgman at (510) 337-6794.
Sincerely,
/s/
Barbara J. Cassens
District Director
No comments:
Post a Comment