483
Sofie Co dba SofieSofie Co dba Sofie – FDA 483, Jul 25, 2025
Record Details
An FDA inspection of Sofie Co dba Sofie, a PET Drug Manufacturer in Sterling, VA, revealed a critical failure in quality control. The firm did not conduct appropriate laboratory determinations to ensure PET drug products met specifications before release. This included inadequate investigations into out-of-specification bacterial endotoxin results, unauthorized retesting, and the release of affected batches without proper confirmatory testing.
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ID · 0e9fc79b-32b0-4058-9e3d-e696ea17120f
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