Overview
- 14 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-03.
At a glance
Inspections
14
Form 483s
4
EIRs
4
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 | Foods & Cosmetics | Clean | |
| 22 Oct 2024 – 30 Oct 2024 | Tobacco Products | Clean | |
| 29 Aug 2023 – 30 Aug 2023 | Foods & Cosmetics | Clean | |
| 20 Jul 2022 – 25 Jul 2022 | Human Drugs | Clean | |
| 19 Jul 2022 – 22 Jul 2022 | Human Drugs | 483 | On file |
| 12 Oct 2021 – 15 Oct 2021 | Human Drugs | 483 | View 483 → |
| 6 Jul 2021 – 9 Jul 2021 | Human Drugs | Clean | |
| 16 Apr 2019 – 17 Apr 2019 | Foods & Cosmetics | Clean | |
| 14 Nov 2017 – 16 Nov 2017 | Human Drugs | 483 | View 483 → |
| 10 Dec 2013 – 12 Dec 2013 | Human Drugs | 483 | View 483 → |
| 4 Aug 2011 | Not recorded | Clean | |
| 20 Aug 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Oct 2021
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Nicole E Knowlton
Investigators
FDA investigators tied to this site in the record.
Sandy L Atkins2 insp.
Demario L Walls2 insp.
Brandon C Heitmeier2 insp.
Kerry-Ann P Latham1 insp.
Shelton L Stribling1 insp.
Regan T Harp1 insp.
Shatina R Alridge1 insp.
Nicole E Knowlton1 insp.
Markeesa M Scales1 insp.
Claire M Minden1 insp.
Cheryl L Watson1 insp.
Danielle M Maddox1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aphena Pharma Solutions - Tennessee LLC's 4 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