Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-20.
At a glance
Inspections
5
Form 483s
5
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2024 – 20 Nov 2024 | Human Drugs | 483 | View 483 → |
| 8 May 2019 – 16 May 2019 | Human Drugs | 483 | View 483 → |
| 12 Feb 2018 – 28 Feb 2018 | Human Drugs | WL | View 483 → |
| 3 Aug 2015 – 7 Aug 2015 | Human Drugs | 483 | View 483 → |
| 7 Nov 2013 – 11 Dec 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2024
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Sean R Marcsisin, James R Birkenstamm, Lori M Newman
20 Nov 2024
21 CFR 212.30(c)
Contact surfaces
Cited by Sean R Marcsisin, James R Birkenstamm, Lori M Newman
20 Nov 2024
21 CFR 212.50(c)(8)
Testing results
Cited by Sean R Marcsisin, James R Birkenstamm, Lori M Newman
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin3 insp.
James R Birkenstamm1 insp.
Lori M Newman1 insp.
Christopher Janik1 insp.
Chad N Thompson1 insp.
Ramon E Martinez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50(c)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind N-Molecular, Inc. dba SOFIE's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat