FDA 483 - Vulto Creamery - March 22, 2017

This FDA Form 483 details observations from an inspection of Vulto Creamery LLC, a cheese manufacturer located at 44 West St, Walton, NY, conducted from February 28, 2017, to March 22, 2017. The owner, Johannes H. Vulto, was issued the report.

The inspection revealed 15 observations indicating significant sanitation and manufacturing deficiencies. Key findings include:

* **Listeria Monocytogenes Contamination:** Finished product samples of Ouleout soft raw milk cheese (Lot #617 and #623) tested positive for *Listeria monocytogenes*. * **Inadequate Microbial Testing and Investigation:** Environmental sampling records from July 2014 to February 2017 showed 54 out of 198 samples positive for *Listeria spp.* from various facility locations, including food contact surfaces. The firm failed to identify the species, source, or harborage of *Listeria*, and did not conduct finished product testing despite food contact surface positives. Re-swabbing after cleaning was delayed, allowing further production. * **Ineffective Cleaning and Sanitizing:** Repeated *Listeria spp.* positives after routine cleaning indicated inadequate procedures, with no investigation into more effective methods. * **Improper Storage of Equipment:** Cleaned and sanitized wooden aging boards were stored in an attic with exposed insulation and debris