Overview
- 14 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-13.
At a glance
Inspections
14
Form 483s
10
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2026 – 13 Apr 2026 | Human Drugs | Clean | |
| 9 Dec 2024 – 18 Dec 2024 | Human Drugs | 483 | View 483 → |
| 24 Jan 2023 – 10 Feb 2023 | Human Drugs | 483 | View 483 → |
| 30 Aug 2021 – 17 Sep 2021 | Human Drugs | 483 | View 483 → |
| 17 Dec 2019 – 7 Jan 2020 | Human Drugs | WL | On file |
| 25 Mar 2019 – 29 Mar 2019 | Human Drugs | 483 | View 483 → |
| 1 Mar 2017 – 8 Mar 2017 | Human Drugs | 483 | View 483 → |
| 20 Oct 2015 – 28 Oct 2015 | Human Drugs | 483 | View 483 → |
| 8 Sep 2014 – 10 Sep 2014 | Human Drugs | Clean | |
| 26 Aug 2013 – 31 Oct 2013 | Human Drugs | 483 | On file |
| 22 Mar 2012 | Not recorded | 483 | On file |
| 2 Apr 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Feb 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Veronica Fuentes, Jessica M Simpson
10 Feb 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Veronica Fuentes, Jessica M Simpson
Investigators
FDA investigators tied to this site in the record.
Veronica Fuentes4 insp.
Joseph F Owens2 insp.
Jawaid Hamid2 insp.
Pratik S Upadhyay1 insp.
Samantha E Cleek1 insp.
Matthew R Coleman1 insp.
Jessica M Simpson1 insp.
Song Y Lavalais1 insp.
Gideon N Esuzor1 insp.
Vanessa E Coulter1 insp.
Larry K Hampton1 insp.
Tamara J Henderson1 insp.
Babatunde D Babalola1 insp.
Lareese K Thomas1 insp.
Ana L Kewes1 insp.
Dellarese L Herbert1 insp.
Hai Lien T Phung1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Acella Pharmaceuticals, LLC's 10 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