Inspections, Compliance, Enforcement, and Criminal Investigations
Basic Food Flavors, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
June 23, 2010
Mr. Kanaiyalal N. Patel
Basic Food Flavors, Inc.
3950 East Craig Road
North Las Vegas, NV 89030-7504
Dear Mr. Patel:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 3950 East Craig Road, North Las Vegas, NV, from February 12, 2010 through March 4, 2010. This inspection revealed that hydrolyzed vegetable protein (HVP) processed by your facility is adulterated within the meaning of section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1) and (a)(4)]. You can find the Act and its associated regulations on the internet through links on the FDA web page at www.fda.gov.
During the inspection, FDA collected a sample of HVP (b)(4) processed at your facility. Laboratory analysis of the HVP product revealed the presence of Salmonella tennessee
(S. tennessee). Salmonella, including the S. tennessee serotype, is a microorganism that is known to be pathogenic to humans. Foods containing Salmonella pose a danger to health and are adulterated within the meaning of Section 402(a)(1) of the Act, in that the products contain a poisonous or deleterious substance which may render them injurious to health. FDA notes that your firm subsequently voluntarily recalled all powdered and paste HVP manufactured on or after September 17, 2009.
In addition, FDA analyzed environmental samples collected from various locations within your fum's processing facility during the inspection. Laboratory analysis of these environmental samples found Salmonella in nine separate subsamples. The positive subsamples were further serotyped and S. tennessee, S. senftenberg, and S. westhampton were isolated from the environmental samples. It was further determined that six of the subsamples to be S. tennessee, the same serotype with an indistinguishable Pulsed-Field Gel Electrophoresis (PFGE) pattern as isolated from the samples of finished product. The recovery of indistinguishable S. tennessee serotype patterns from multiple processing locations, including direct food contact surfaces, within your facility indicates that Salmonella may have become established in a niche environment in your facility. Further, finding Salmonella on direct food contact surfaces and other areas very near to where food is exposed indicates a high risk of product contamination. Based on our analytical and inspection findings, we determined that your firm's HVP products were adulterated within the meaning of Section 402(a)(4) of the Act, in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health.
Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
FDA's inspection also revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). We reviewed your firm's written response from (b)(4) dated March 12, 2010, to the Form FDA-483, in which you state you have corrected or promise to correct the deficiencies listed. In addition to the voluntary recall of HVP manufactured on or after September 17, 2009, your promised corrections include (b)(4); implementation of new procedure, including training, to minimize the potential of microbial contamination of food products; revising and updating your (b)(4); revising and updating your (b)(4) program, including (b)(4) and reviewing and amending as appropriate your (b)(4) program. Please submit documentation which shows implementation of your completed corrections including (b)(4) and contract work to (b)(4), detailed information on how you will minimize movement of personnel/material/equipment in the primary Salmonella control areas, how you intend to monitor the (b)(4), information about your (b)(4) program, and specifically, your intended corrective actions should include (b)(4) monitoring detect a possible sanitation failure. Your submission should also include revise (b)(4) and operating procedures related to (b)(4) as well as training materials you have developed for employees to minimize microbial contamination. The adequacy of your corrective actions and their implementation will be assessed during our next inspection.
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 the Act and applicable FDA regulations. Failure to correct violations of the Act and applicable regulations may result in regulatory action without further notice, such as seizure and/or injunction.
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 since your March 12, 2010 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: Russell A. Campbell, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA. If you have questions regarding any issue in this letter, please contact Russell Campbell at (510) 337-6861.
Gerald J. Berg
Acting District Director
San Francisco District
U. S. Food and Drug Administration
Glenn D. Savage, REHS
Environmental Health Director
Southern Nevada Health District
P.O. Box 3902
Las Vegas, Nevada, 89127
State of Nevada
Department of Health and Human Services
4150 Technology Way
Carson City, NV 89706