BOULDER BIOMED DBA BOULDER IQ – FDA 483, Oct 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.
ID · 83d1ab03-a915-4455-818e-da2ad90963a7
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