MISSION LLC – FDA Warning Letter, Aug 5, 2019

The FDA issued a Warning Letter to Mission, LLC on February 6, 2020, following Foreign Supplier Verification Program (FSVP) inspections on August 2 and 5, 2019, and previously on July 17-18, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The primary violation identified was Mission, LLC's failure to have an FSVP for any imported food products, including black tea from foreign supplier (b)(4). This was a repeat violation from the 2018 inspection. The FDA acknowledged the firm's August 16, 2019, response, which included the foreign manufacturer's HACCP Plan and hazard analysis.

However, the FDA noted that Mission, LLC did not provide evidence of documenting their review and assessment of the foreign supplier's hazard analysis, as required by 21 CFR 1.504(d). Furthermore, the foreign supplier's hazard analysis was deficient, failing to list specific microorganisms or pathogens (e.g., *Bacillus cereus*, *Salmonella spp.*) and omitting mycotoxins (e.g., aflatoxin, ochratoxin A) as known or reasonably foreseeable chemical hazards. The FDA emphasized that meeting hazard analysis requirements alone is insufficient, as FSVP also mandates foreign supplier