FDA 483 - El Borincano Feed Mills, Inc - July 26, 2021

El Borincano Feed Mills, Inc., an animal feed manufacturer in Toa Alta, PR, was issued an FDA Form 483 following an inspection conducted from July 20-26, 2021. The inspection highlighted multiple significant violations of federal animal food safety regulations, many of which were repeat observations from previous inspections in 2019 and 2018, indicating a persistent lack of compliance.Key issues included the absence of a written food safety plan and a failure to establish procedures for evaluating raw materials susceptible to mycotoxin or other natural toxin contamination. Investigators also observed unlabelled bulk raw material containers, with one found to contain a discarded food item in direct contact with the feed ingredient, posing a significant contamination risk.Furthermore, the facility exhibited inadequate sanitation and maintenance, including spilled oil, poorly maintained equipment, and open access points that could allow pest entry, potentially adulterating animal feed. The firm also lacked documented employee training records for animal food hygiene and safety, even for designated Preventive Controls Qualified Individuals. To address these serious deficiencies, El Borincano Feed Mills, Inc. is expected to develop and implement comprehensive corrective actions to achieve compliance with FDA regulations and safeguard animal feed products.