FDA Inspection
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA Inspection, Jan 20, 2023
Record Details
This FDA Inspection record concerns SOFIE Co. dba SOFIE, with an inspection on January 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Guerlain Ulysse (FDA Associated Person)
- JoshRenzo N. Ramilo
- Monika Borkowska Petrik (Issuing Officer)
View Company Profile
ID · 45f7f703-eb06-4086-8792-6fb1746b27f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195181
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 212.60(e)Equipment
- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.71(c)Correction of problems
- 21 CFR 212.100(a)Written complaint procedures
- 21 CFR 212.70(b)Before implementing new procedure establish and document accuracy etc.
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.100(a)Written complaint procedures
- 21 CFR 212.20(d)Determination need for investigation
Showing 10 of 16 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SOFIE Co. dba SOFIE
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2018 | Not classified | New Jersey District Office | |
| June 24, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SOFIE Co. dba SOFIE
- FDA Inspection 1048176 - 2018-02-28
- FDA Inspection 931454 - 2015-06-24
- FDA Inspection 769657 - 2012-02-28
- FDA Inspection 680504 - 2010-09-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.