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FDA Inspection
•SOFIE Co. dba SOFIE•April 21, 2026

SOFIE Co. dba SOFIE – FDA Inspection, Apr 21, 2026

Record Details

This FDA Inspection record concerns SOFIE Co. dba SOFIE, with an inspection on April 21, 2026, issued by the Dallas District Office, covering human drugs.

Company
SOFIE Co. dba SOFIE
Inspection Date
April 21, 2026
Product Type
Human Drugs
Office
Dallas District Office
Person
  • Youkeun Kim
View Company Profile

ID · 9f97f7aa-21b4-490d-9d7d-a4ffd9f3575a

Inspection Facts

Inspection number
1313566
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 212.30(b)Equipment procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SOFIE Co. dba SOFIE

3
DateClassificationOfficeProject area
January 15, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 27, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 22, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for SOFIE Co. dba SOFIE
  • FDA Inspection 1076429 - 2019-01-15
  • FDA Inspection 970671 - 2016-05-27
  • FDA Inspection 854064 - 2013-10-22

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