WASHINGTON — The US Food and Drug Administration (FDA) issued a warning letter to ReConserve Inc., an American food and animal food producer, on Jan. 3 detailing notable violations of CGMPs, Hazard Analysis, and Risk-Based Preventive Controls at its Baltimore facility.

Inspections were conducted between May 23 and June 29, 2023, and ReConserve issued a response to the FDA on July 14. However, the recent warning letter suggests the manufacturer has not made sufficient steps toward rectifying the issues observed at the inspections.

In the letter, the FDA described violations regarding ingredient storage conditions, in which agency representatives observed “filthy, putrid, or decomposed substance” in its animal food products, which is considered adulteration. This includes a pile of human food bakery byproducts deemed for animal food production that had been left in a 3-foot-high pile outdoors, uncovered, and was found exposed to birds and insects, foreign objects and weather conditions.

Additionally, investigators witnessed discarded materials stored against an outside wall of the manufacturing facility on May 24 and June 7, 2023, which could elevate the risk of pests.

The FDA stated ReConserve had not conducted a proper hazard analysis to identify and prevent animal food manufacturing, processing, packing or storage risks at the Baltimore facility. The company also failed to establish preventive controls or written procedures to address these risks.

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