FDA Warns Pet Food Manufacturer After Facility Inspection

The Food and Drug Administration (FDA) issued a warning letter to ReConserve on January 3, 2024, following an investigation prompted by a complaint from a state regulatory partner about ingredient storage conditions. FDA inspected the facility from May 23 to June 29, 2023.

ReConserve is a recycler of bakery, cereal grain, snack foods, and related food byproducts in the US by converting leftover, expired, and inedible bakery waste into pet food ingredients.

The letter to ReConserve President David Luskin describes the conditions FDA found at the facility:

During the inspection, an FDA Investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals requirements, which cause your products to be adulterated. Additionally, this inspection found evidence that your product is adulterated because it consists in whole or in part of a filthy, putrid, or decomposed substance. The introduction or delivery for introduction into interstate commerce of any food that has been adulterated is a prohibited act. Also, the failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of 21 CFR Part 507 is a prohibited act.

ReConserve replied in July 2023, and FDA found that the company did not examine its raw materials and other ingredients to ensure they were suitable for manufacturing and processing into animal food and did not handle them under conditions that will protect against contamination and minimize deterioration as required.

The FDA Investigator observed human food bakery byproducts intended for use as an ingredient outside, piled on gravel ground and uncovered. The investigator found the ingredients to be deteriorated and containing foreign material such as gravel, rocks, soil, mud, unidentifiable substances, and unknown man-made foreign materials. Wild birds were seen feeding on the pile and insects were observed on the pile. The pile is exposed to contaminations from weather conditions including rainfall, and rainwater runoff with chemicals from nearby trucks and industrial equipment.

 The agency had concerns that the outdoor ingredient pile was unfit for food and considered the outdoor ingredient pile to be adulterated due to the observed conditions of the ingredients and pest activity. 

Yet ReConserve continued to use these ingredients after it had stopped just three weeks later without conducting an evaluation to determine if the ingredients were fit for food. The company stated in its response that its manufacturing process is designed to remove foreign material and the color difference in the ingredients stored outside from ingredients stored inside is due to chocolate products being mixed into only the outdoor pile. 

The first response in July 2023 did not address the issues FDA wanted resolved. ReConserve must send FDA a revised response regarding its findings outlining specific steps the company is taking to correct the violations.