Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2026 – 21 May 2026 | Human Drugs | 483 | View 483 → |
| 7 Aug 2024 – 13 Aug 2024 | Human Drugs | 483 | On file |
| 5 Mar 2018 – 29 Mar 2018 | Human Drugs | 483 | View 483 → |
| 6 May 2014 – 15 May 2014 | Human Drugs | Clean | |
| 20 Sep 2012 | Not recorded | Clean | |
| 22 Mar 2012 | Not recorded | Clean | |
| 8 Jul 2011 | Not recorded | Clean | |
| 19 Jan 2010 | Not recorded | 483 | View 483 → |
| 9 Jul 2009 | Not recorded | Clean | |
| 19 Dec 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Logan T Williams, Anna M Spiros, Supreet K Sran
21 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Logan T Williams, Anna M Spiros, Supreet K Sran
21 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Logan T Williams, Anna M Spiros, Supreet K Sran
21 May 2026
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Logan T Williams, Anna M Spiros, Supreet K Sran
29 Mar 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Nicholas L Paulin, Andrew J Barrowcliff, Jazmine N Still
Investigators
FDA investigators tied to this site in the record.
Janet L Bowen3 insp.
Michael P Sheehan2 insp.
Mary E Storch2 insp.
Logan T Williams1 insp.
Anna M Spiros1 insp.
Supreet K Sran1 insp.
Nicholas L Paulin1 insp.
Andrew J Barrowcliff1 insp.
Jazmine N Still1 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 | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Oakwood Laboratories 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