Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-27.
At a glance
Inspections
13
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2026 – 27 Feb 2026 | Human Drugs | 483 | View 483 → |
| 18 Nov 2024 – 19 Nov 2024 | Human Drugs | 483 | View 483 → |
| 5 Aug 2019 – 12 Aug 2019 | Human Drugs | 483 | View 483 → |
| 11 Jan 2018 – 24 Jan 2018 | Human Drugs | 483 | View 483 → |
| 24 Jan 2017 – 31 Jan 2017 | Human Drugs | Clean | |
| 12 Mar 2014 – 18 Mar 2014 | Human Drugs | Clean | |
| 17 Nov 2011 | Not recorded | Clean | |
| 21 Dec 2010 | Not recorded | Clean | |
| 24 Mar 2010 | Not recorded | Clean | |
| 2 May 2008 | Not recorded | Clean | |
| 20 Feb 2004 | Not recorded | Clean | |
| 7 Mar 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer Lalama, Amit Kokate
27 Feb 2026
21 CFR 211.68(b)
Computer control of master formula records
Cited by Jennifer Lalama, Amit Kokate
Investigators
FDA investigators tied to this site in the record.
Penny H Mccarver2 insp.
Jennifer Lalama1 insp.
Amit Kokate1 insp.
Susan O Oladeji1 insp.
Veronica Fuentes1 insp.
Pratik S Upadhyay1 insp.
Joseph F Owens1 insp.
Tamara J Henderson1 insp.
Trang N Cox1 insp.
Tamika D Cathey1 insp.
Gabriel R Mclemore1 insp.
Jason F Chancey1 insp.
Hai Lien T Phung1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Societal CDMO Gainesville, 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