FDA 483 - AVASOL LLC - February 12, 2025

AVASOL LLC in Santa Barbara, CA, was issued a Form 483 with four observations following an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit, including incomplete and unfollowed procedures for process validations, equipment qualifications, and cleaning validations. Additionally, the inspection revealed issues with equipment cleaning logs, instrument calibration procedures, and the investigation of unexplained discrepancies, indicating a lack of robust quality system controls for drug product manufacturing.