Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-17.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Oct 2025 – 17 Oct 2025 | Biologics | 483 | On file |
| 3 Feb 2025 – 7 Feb 2025 | Biologics | 483 | View 483 → |
| 7 Oct 2024 – 11 Oct 2024 | Biologics | 483 | On file |
| 14 Nov 2023 – 17 Nov 2023 | Biologics | Clean | |
| 21 Aug 2023 – 25 Aug 2023 | Biologics | 483 | On file |
| 20 Jan 2015 – 23 Jan 2015 | Biologics | Clean | |
| 30 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Scott T Ballard, Christian Lynch
7 Feb 2025
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Scott T Ballard, Christian Lynch
7 Feb 2025
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Scott T Ballard, Christian Lynch
7 Feb 2025
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Scott T Ballard, Christian Lynch
Investigators
FDA investigators tied to this site in the record.
Christine Harman2 insp.
Shaina R Fullwood1 insp.
Scott T Ballard1 insp.
Christian Lynch1 insp.
Matthew W Klinker1 insp.
Ou Ma1 insp.
Grace I Cortesini1 insp.
Brenton K Mccright1 insp.
Laressa R Gray1 insp.
Wei Wang1 insp.
Donald B Ertel1 insp.
Prajakta A Varadkar1 insp.
Zhaohui Ye1 insp.
Hoda N Abadeer1 insp.
Jessica Chery1 insp.
Donna D Gallien1 insp.
Melanie L Drayton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GI Accelerate Memphis LLC's 4 Form 483s
Source PDFs 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