483
Biogennix LLCFDA 483 - Biogennix LLC - February 08, 2024
Record Details
Biogennix LLC in Irvine, CA, was inspected by the FDA, revealing significant deficiencies in their quality system. The firm failed to adequately maintain complaint files, establish effective corrective and preventive action procedures, and control nonconforming products. These issues indicate a lack of adherence to established quality management practices.
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ID · 9f7c328c-e349-48c3-b695-7ba6594d6ceb