WASHINGTON — The US Food and Drug Administration (FDA) issued a warning to ReConserve Inc., an American food and animal food producer, on January 3 detailing significant violations of CGMPs, Hazard Analysis, and Risk-Based Preventive Controls in its Baltimore facility.
The inspections were conducted between May 23 and June 29, 2023, and ReConserve provided a response to the FDA on July 14. However, the recent warning letter suggests that the manufacturer did not take sufficient steps toward correction on issues observed during inspections.
In the letter, the FDA described violations regarding ingredient storage conditions, where agency representatives observed “dirty, rotten, or decaying substances” in its animal food products, which are considered adulteration. It included a pile of human food bakery byproducts that had been considered for animal food production that had been left in a 3-foot-high pile outside, uncovered, and found exposed to birds and insects, foreign objects and weather conditions.
Additionally, investigators witnessed discarded materials stored outside the wall of the manufacturing facility on May 24 and June 7, 2023, which could increase the risk of pests.
The FDA said ReConserve did not conduct a proper risk analysis to identify and prevent risks in the production, processing, packaging, or storage of animal feed at the Baltimore facility. The company also failed to establish preventive controls or written procedures to address these risks.
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