FDA WARNING_LETTER - Ventura Terra Garden Inc. - April 29, 2020

On April 15-17, 20-21, and 29, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Ventura Terra Garden Inc., initiated due to enoki mushrooms from a foreign supplier being associated with a *Listeria monocytogenes* outbreak. The firm's food safety manager provided a voluntary recall press release from Forest Mushroom Food Inc., dba Guan’s Mushroom Co., dated March 23, 2020, for enoki mushrooms potentially contaminated with *Listeria monocytogenes*. FDA analysis of enoki mushroom samples also revealed the presence of *Listeria monocytogenes*.

The inspection found the firm not in compliance with 21 CFR part 1 subpart L for fresh packaged enoki mushrooms, lacking an FSVP for this product and presenting non-compliant FSVP documents. Significant violations include: 1. No written hazard analysis to identify and evaluate known or reasonably foreseeable hazards (21 CFR 1.504(a)). The firm also failed to document review and assessment of the foreign supplier’s hazard analysis (21 CFR 1.504(d)). 2. An onsite audit of the foreign supplier did not consider the FSMA Produce Safety Rule as an applicable food safety regulation (21 CFR 1.506(e)(1)(i)(B)). 3. Failure to