483
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA 483, Jun 12, 2026
Record Details
SOFIE Co dba Sofie, a PET Drug Manufacturer in Miami Lakes, FL, was cited for significant deficiencies during a pre-approval inspection. Observations included failures in component identity testing, inadequate aseptic processing techniques by personnel, and a lack of robust quality assurance procedures. The firm also demonstrated insufficient production and process controls to ensure consistent drug product quality.
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ID · 29b81107-9eef-4274-ae1e-3ec3548b6641
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