Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-20.
At a glance
Inspections
9
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2026 – 20 Feb 2026 | Human Drugs | 483 | View 483 → |
| 3 May 2022 – 6 May 2022 | Human Drugs | 483 | View 483 → |
| 7 Dec 2021 – 15 Dec 2021 | Human Drugs | 483 | View 483 → |
| 16 Apr 2018 – 20 Apr 2018 | Human Drugs | 483 | On file |
| 8 Sep 2015 – 10 Sep 2015 | Human Drugs | Clean | |
| 25 Jun 2013 – 27 Jun 2013 | Human Drugs | 483 | View 483 → |
| 13 Jan 2012 | Not recorded | 483 | View 483 → |
| 5 Jan 2011 | Not recorded | 483 | View 483 → |
| 9 Dec 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Ofuje D Daniyan
20 Feb 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by David A Oluwo, Ofuje D Daniyan
6 May 2022
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Sena G Dissmeyer, Brandy N Lepage
6 May 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sena G Dissmeyer, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Nebil A Oumer2 insp.
David A Oluwo1 insp.
Ofuje D Daniyan1 insp.
Sena G Dissmeyer1 insp.
Brandy N Lepage1 insp.
Mindy M Chou1 insp.
Roseline N Boateng1 insp.
Juliana M Badalucco1 insp.
Zakaria I Ganiyu1 insp.
Shusheen A Alexander1 insp.
Ernest Bizjak1 insp.
Jesse P Hardin1 insp.
Merideth K Rose1 insp.
Gale L Glinecki1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aphena Pharma Solutions - Maryland, LLC's 7 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