Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 Jan 2023
21 CFR 212.100(a)
Written complaint procedures
Cited by Guerlain Ulysse, Monika Borkowska, Josh Renzo N Ramilo
20 Jan 2023
21 CFR 212.20(d)
Determination need for investigation
Cited by Guerlain Ulysse, Monika Borkowska, Josh Renzo N Ramilo
20 Jan 2023
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Guerlain Ulysse, Monika Borkowska, Josh Renzo N Ramilo
20 Jan 2023
21 CFR 212.30(b)
Equipment procedures
Cited by Guerlain Ulysse, Monika Borkowska, Josh Renzo N Ramilo
20 Jan 2023
21 CFR 212.50
Adequate controls (general)
Cited by Guerlain Ulysse, Monika Borkowska, Josh Renzo N Ramilo
Inspected site
SCSOFIE Co. dba SofieSomerset, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(c) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere