Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-21.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 21 Aug 2025 | Human Drugs | 483 | On file |
| 25 Jun 2019 – 28 Jun 2019 | Human Drugs | 483 | On file |
| 17 Feb 2017 – 1 Mar 2017 | Human Drugs | 483 | On file |
| 4 Jan 2016 – 12 Jan 2016 | Human Drugs | 483 | View 483 → |
| 25 Oct 2012 | Not recorded | 483 | View 483 → |
| 4 Feb 2011 | Not recorded | 483 | View 483 → |
| 14 Nov 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jan 2016
21 CFR 211.166(a)(2)
Stability sample storage conditions described
Cited by Robert J Ham, Dewayne E Whitlock
12 Jan 2016
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Robert J Ham, Dewayne E Whitlock
12 Jan 2016
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Robert J Ham, Dewayne E Whitlock
12 Jan 2016
21 CFR 211.22(a)
Approve or reject components, products
Cited by Robert J Ham, Dewayne E Whitlock
Investigators
FDA investigators tied to this site in the record.
Mary L Schuckmann1 insp.
Norman K Starks1 insp.
Michele Perry-Williams1 insp.
Robert J Ham1 insp.
Dewayne E Whitlock1 insp.
Shafiq Ahadi1 insp.
Steven D Kehoe1 insp.
Michele Perry Williams1 insp.
Cynthia M Goudeau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Buckeye International Inc'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