483
SOFIE Co. dba SOFIEFDA 483 - SOFIE Co. dba SOFIE - April 21, 2026
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Record Details
An FDA inspection of SOFIE Co. dba SOFIE in Dallas, TX, a PET drug manufacturer, identified a significant deficiency related to equipment cleaning and suitability. The firm failed to implement and document procedures to ensure equipment, specifically a hot cell, was properly maintained and cleaned. This lapse creates a contamination risk for materials used in aseptic operations.
- Office
- Dallas District Office
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ID · e4a6150c-e487-420b-8003-a7ebb9a632f4