Inspections, Compliance, Enforcement, and Criminal Investigations
U.F. Union International Food Company, 11/24/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Our reference # 2918563
November 24, 2009
Daniel Chen, Vice President & Manager
U.F. Union International Food Company, Inc.
33035 Transit Avenue
Union City, CA 94587-2043
Dear Mr. Chen:
The Food and Drug Administration (FDA) conducted an inspection of your spice processing facility located at 33035 Transit Avenue, Union City, CA from March 27 through July 24,2009. This inspection confirmed that you processed and introduced into interstate commerce white pepper products that were adulterated within the meaning of section 402(a)(l) [21 U.S.C. §342(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act). We have also determined, based on the results of this inspection, that your white pepper products and other spice products are adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(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, samples of finished white pepper products processed at your facility were collected and analyzed by FDA. FDA analysis of two of these samples revealed the products to be contaminated with Salmonella enterica subsp. enterica serovar Rissen (S. rissen). Salmonella, including S. rissen, is a micro-organism 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)(l) [21 U.S.C. § 342(a)(1)] of the Act, in that the products contain a poisonous or deleterious substance (Salmonella) which may render the product injurious to health. We note that your distributed white pepper products were subject to a voluntary recall action in 2009.
In addition to the finished product samples, FDA analyzed environmental samples collected from various locations within your firm's processing facility during the inspection. The analysis of these environmental samples found Salmonella in fourteen subsamples collected from separate processing locations, including your white pepper grinding room. The finding of Salmonella in multiple processing locations within your facility indicates that this pathogenic organism may have become established in a niche environment in your facility. Each of these positive subsamples was further serotyped and determined to be S. rissen, the same serotype with an indistinguishable Pulsed-Field Gel Electrophoresis (PFGE) pattern as isolated from the samples of finished product. Finding Salmonella very near to where food is exposed indicates a high risk of product contamination. Based on our analytical and inspectional findings, your firm's pepper and other spice products are adulterated within the meaning of Section 402(a)(4) of the Act, [21 U.S.C. § 342(a)(4)], in that they have been 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.
Further, serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CPR 110), including possible routes of cross-contamination, were identified by our investigators and documented on the Form FDA-483, Inspectional Observations, issued to your firm on July 24, 2009. We acknowledge that you initiated corrections prior to the conclusion of the inspection. When our investigators reviewed these corrections, it appeared that the significant CGMP deviations had been adequately addressed. The adequacy of your corrections will be verified during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your establishment operates in compliance with the Act and the CGMP regulation (21 CFR Part 110). Failure to implement lasting corrective action of these violations and prevent their recurrence may result in regulatory action being initiated by FDA without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 [21 U.S.C. §§ 332 and 334]. In addition, section 303(a)(1) of the Act [21 U.S.C. § 333(a)(I)] provides that there is criminal liability for all violations of the prohibited acts described in section 301 of the Act [21 U.S.C. § 331].
We are aware that the State of California filed a stipulated preliminary injunction against your firm, entered by the Superior Court of the State of California for the County of Alameda, on May21, 2009, and that you are currently instituting actions to comply with the requirements of that injunction. During the inspection, the California Department of Public Health, Food and Drug Branch (FDB) reported that they had also collected and analyzed samples of white pepper, including a sample of intact raw whole white pepper and samples of in-process ground white pepper, as well as several environmental samples, which their lab analysis found positive for Salmonella. The samples that were further serotyped were determined to be S. rissen. On August 4, 2009, after the close of the inspection, the FDB along with FDA returned to your firm and collected environmental swab samples, all of which were found negative for Salmonella.
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 and the specific steps that you have taken to correct the noted violations. Your response should include any documentation necessary to show that correction has been achieved. 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: Juliane K. Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issue in this letter, please contact Compliance Officer Jung-Lau at (510) 337-6793.
Barbara J. Cassens
cc: Yung-Pun Huang, President
U.F. Union International Food Co.
Nantong Chau Tau Tsuen Road Town on the 11th
Minhou County, Fuzhou, Fujian China 350112