FDA 483 - North American Science Associates Inc - July 24, 2025

North American Science Associates, LLC in Irvine, CA, received a Form 483 citing significant deficiencies in their control laboratory operations. Observations included inadequate maintenance of aseptic processing equipment, failures in environmental and personnel monitoring, and a lack of thorough investigation into discrepancies. Additionally, the firm was cited for issues with annual record reviews and for not making required documents readily available during the inspection.