Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-12-11.
At a glance
Inspections
6
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2019 – 11 Dec 2019 | Human Drugs | 483 | View 483 → |
| 10 Oct 2017 – 18 Oct 2017 | Human Drugs | 483 | View 483 → |
| 9 Jan 2017 – 20 Jan 2017 | Human Drugs | 483 | View 483 → |
| 21 Sep 2015 – 2 Oct 2015 | Human Drugs | 483 | View 483 → |
| 21 Sep 2015 – 1 Oct 2015 | Human Drugs | 483 | On file |
| 12 Aug 2013 – 16 Aug 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jennifer L Huntington, Ileana Barreto-Pettit
18 Oct 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jennifer L Huntington, Ileana Barreto-Pettit
18 Oct 2017
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer L Huntington, Ileana Barreto-Pettit
18 Oct 2017
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer L Huntington, Ileana Barreto-Pettit
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit4 insp.
Joanne E King3 insp.
Jennifer L Huntington2 insp.
Miguel A Martinez2 insp.
Jennifer Lalama1 insp.
Steven J Rush1 insp.
Ivis L Negron Torres1 insp.
Jingbo Xiao1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SOFGEN PHARMACEUTICALS LLC's 6 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