Is Etai's Food, Inc Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

L. monocytogenesis a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Consuming foods contaminated withL. monocytogenescan lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.

Whole Genome Sequencing (WGS) analysis was conducted on the eight (8)L. monocytogenesisolates obtained from the FDA environmental samples during the inspection. WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis of these eight (8) isolates finds that they comprise a single strain ofL. monocytogenes. The presence ofL. monocytogenesin your facility is significant in that it demonstrates that your sanitation efforts are inadequate to effec

We reviewed your response letter dated December 9, 2016, written in response to the Form FDA 483.  Your response described various actions your firm has taken including retaining a consultant to advise you regarding environmental sanitation design, chemical treatment, and procedures; revising your cleaning and sanitizing programs; updating your SSOP; hiring a specific crew of personnel to conduct the cleaning and sanitizing after production runs; and adding a cleaning verification step to include(b)(4)swabbing. However, we cannot evaluate the adequacy of your response because your response lacked certain information, including a copy of your updated SSOP. We will assess the adequacy of your corrective actions during our next inspection.Seafood HACCP Violations:

Potential Health Risks

The Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 101 East 70th Avenue, Denver, CO, on October 4 through November 10, 2016.  During the inspection, FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces.  FDA laboratory analyses of the environmental swabs identified the presence ofListeriamonocytogenes (L. monocytogenes),a human pathogen, in your facility. We have determined that your Ready-To-Eat (RTE) food products, including your RTE salads, are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary co

Regulatory Context

Further, our investigator obtained product labeling during the inspection for several of your products. We have reviewed these labels and found violations of the food labeling regulations, 21 CFR Part 101, that cause your products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].

You may find the Act, seafood HACCP regulations, and the 4th Edition of FDA’s Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page atwww.fda.gov.

This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s response to the FDA-483 dated December 9, 2016, which includes a description of corrective actions taken by your firm. We address your response below.