FDA 483 - Eagle Analytical Services, Inc. - November 21, 2025

Eagle Analytical Services, Inc. in Houston, TX, a contract testing laboratory, received a Form 483 citing significant deficiencies in its quality control and aseptic processing operations. The inspection revealed failures in conducting dynamic airflow visualization studies, inadequate investigation of non-conformances and deviations, and poor document control practices. These observations highlight a lack of robust quality oversight and adherence to established procedures for ensuring product sterility and data integrity.