FDA EIR - Crunch Pak LLC - April 15, 2021

An FDA surveillance inspection of Crunch Pak, LLC in Cashmere, WA, was conducted from April 12-15, 2021. This comprehensive inspection, carried out under 21 CFR 117 Preventive Controls, included a full-scope review of the firm's food safety plan and environmental swabbing for Listeria monocytogenes. The previous inspection in April 2019 had identified issues related to inadequate cleaning/sanitation and personnel practices, which were confirmed as corrected during the current visit.

While no formal FDA Form 483 (Inspectional Observations) was issued, several items requiring attention were discussed with management. These included a hose found submerged in sanitizing water, the need to explicitly include calibration in the HACCP plan's verification step for a Critical Control Point, condensation leakage from a refrigeration unit, insufficient space in a handwashing/garment changing area, and improper storage of an animal feed shovel. Differences in the firm’s hazard analysis were also discussed, specifically regarding potential biological hazards in cheddar cheese and for Clostridium botulinum in reduced oxygen packaged products, with the firm providing justifications.

Crunch Pak management committed to making corrections for all discussed observations. Environmental samples collected during the inspection were classified as Lab Class I, indicating no immediate critical findings related to Listeria monocytogenes. This outcome reflects a generally compliant operation with opportunities for minor improvements identified through discussion.