FDA 483 - Southwest Bio-Labs, Inc. - March 19, 2020

An FDA inspection of Southwest Bio-Labs, Inc. in Las Cruces, NM, a GLP facility, revealed 15 observations indicating significant non-compliance with Good Laboratory Practices. Deficiencies included a lack of independence in the quality assurance unit, inadequate equipment maintenance and environmental controls, and failures in adhering to study protocols. The report highlights systemic issues in documentation, adverse event reporting, and the archiving of raw data and specimens.