SOFIE Co. dba SOFIEAugust 7, 2025

FDA 483 - SOFIE Co. dba SOFIE - August 07, 2025

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Record Details

SOFIE Co. dba SOFIE in Gilroy, CA, a PET drug manufacturer, was inspected and received a Form 483 with three observations. The inspection revealed significant deficiencies in equipment cleaning and sanitization procedures, inadequate batch release processes lacking verification of pre-production cleaning and electronic data review, and issues with personnel training record management. These findings indicate a moderate level of non-compliance with GMP regulations.

Company: SOFIE Co. dba SOFIE
Inspection Date: August 7, 2025
Product Type: Drugs
Office: San Francisco District Office
Person: Christopher R. Czajka (Consumer Safety Officer (Inspector))

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ID · 9eb8efa4-a0b0-4e3b-bab5-9563b9e26401