FDA WARNING_LETTER - The North West Company International, Inc. - May 06, 2011

On April 19, 20, 26, 27, and May 6, 2011, the FDA inspected The North West Company International, Inc.'s food storage facility in Tacoma, Washington. The inspection revealed serious violations of 21 CFR Part 110, Current Good Manufacturing Practice, rendering food stored at the facility adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions and potential contamination.

Key violations included failure to protect against pest contamination (21 CFR 110.35(c)), evidenced by dead and twitching rodents, numerous rodent-gnawed flour bags, and extensive rodent excreta pellets found on food packaging and throughout the warehouse floor. Laboratory analysis confirmed rat excreta and the presence of various insects.

Additionally, the facility failed to provide adequate pest protection (21 CFR 110.20(b)(7)), with observed gaps in a personnel door, bay door levelers, and around a gas pipe, allowing pest entry.

The FDA acknowledged the firm's voluntary corrective actions, including increased surveillance, a commitment to create an Integrated Pest Management Process, and the voluntary destruction of rodent-damaged flour and dog food. The firm was required to respond within fifteen working days, detailing specific corrective steps and a timeline for completion, to avoid further regulatory action such as seizure or injunction.