In the midst of ongoing salmonella and listeria outbreaks involving red pepper/black pepper/salami and Queseria Bendita cheese, we will file a lawsuit tomorrow in Oakland on behalf of the family of an elderly woman who died in April 2009 after ingesting white pepper contaminated by Salmonella rissen bacteria. The defendants are the companies that manufactured and distributed the contaminated product. It is apparent from the FDA’s investigation records, and from letters the FDA sent to Union International, the spice company that manufactured the contaminated product, that the production environment had many critical food handling and production problems that contributed to the outbreak.
During the FDA’s inspection of Union International, fourteen swabs taken from different locations at the production facility tested positive for Salmonella. Regarding the concerning findings, the FDA advised the company in a November 24, 2009 letter sent to Daniel Chen, Vice President & Manager, that:
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)],
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
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].
The company immediately acted to correct the violations, but not before a lot of people were sickened in a major outbreak in the western United States. Suit will be filed tomorrow on behalf of a woman who died as a result of Union International’s and supplier’s mistakes.