FDA 483 - BOULDER BIOMED DBA BOULDER IQ - October 30, 2023

An FDA inspection of BOULDER BIOMED DBA BOULDER IQ, a contract manufacturer and sterilizer in Boulder, CO, revealed significant deficiencies across multiple quality system areas. The firm failed to adequately validate its sterilization processes, establish effective corrective and preventive action procedures, and control non-conforming products. Additionally, issues were noted with supplier management and general process control procedures, indicating a broad lack of adherence to established quality requirements.