FDA WARNING_LETTER - Nature Pure LLC - March 02, 2011

The FDA issued a Warning Letter to Nature Pure LLC following inspections on February 7-16, 2011, and February 28-March 2, 2011, of their shell egg production facility. Environmental samples from three egg layer houses tested positive for Salmonella Enteritidis (SE). The inspections revealed significant violations of the Prevention of Salmonella Enteritidis in Shell Eggs regulation (21 CFR Part 118), rendering the firm's shell eggs in violation of the PHS Act and adulterated under the FFD&C Act due to insanitary conditions. Specific deficiencies included the failure to maintain records for egg sampling procedures (21 CFR 118.10(a)(3)(v)) and the failure to test pullet environments for SE at the required 14-16 weeks of age (21 CFR 118.4(a)(2)(i)). Furthermore, the firm's written SE prevention plan lacked essential cleaning and disinfection procedures for use when environmental tests are positive for SE (21 CFR 118.4(d)), and an appropriate monitoring method for flies (21 CFR 118.4(c)(2)). The FDA also commented on the need for appropriate environmental testing equipment and data to demonstrate equivalency of the firm's SE detection method to the FDA-referenced method (21 CFR 118.8(a)). Nature Pure LLC was required to notify the FDA within fifteen working days of specific corrective actions taken or planned, with documentation, to prevent recurrence of these violations. Failure to comply could lead to legal action, including seizure or injunction.