Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-28.
At a glance
Inspections
12
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 28 Aug 2025 | Human Drugs | 483 | View 483 → |
| 19 Nov 2024 – 19 Feb 2025 | Foods & Cosmetics | Clean | |
| 13 Sep 2021 – 21 Sep 2021 | Foods & Cosmetics | Clean | |
| 19 Aug 2019 – 20 Aug 2019 | Human Drugs | Clean | |
| 3 Oct 2016 – 28 Oct 2016 | Foods & Cosmetics | Clean | |
| 26 Apr 2016 – 28 Apr 2016 | Foods & Cosmetics | Clean | |
| 17 Feb 2012 | Not recorded | 483 | View 483 → |
| 3 Dec 2010 | Not recorded | 483 | View 483 → |
| 17 Jul 2009 | Not recorded | Clean | |
| 11 Sep 2008 | Not recorded | Clean | |
| 18 Aug 2006 | Not recorded | Clean | |
| 4 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Aug 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Ogechi C Nna, Azeezat M Lawal
17 Feb 2012
21 CFR 211.67(b)
Written procedures fail to include
Cited by Justin A Boyd, Rebecca L Mullikin, Patrick J Campbell
17 Feb 2012
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Justin A Boyd, Rebecca L Mullikin, Patrick J Campbell
17 Feb 2012
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Justin A Boyd, Rebecca L Mullikin, Patrick J Campbell
17 Feb 2012
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Justin A Boyd, Rebecca L Mullikin, Patrick J Campbell
Investigators
FDA investigators tied to this site in the record.
Jesse P Romenesko5 insp.
Patrick J Campbell3 insp.
Rebecca L Mullikin2 insp.
Ogechi C Nna1 insp.
Azeezat M Lawal1 insp.
Karen M Gasperic1 insp.
Norman K Starks1 insp.
Kenneth A Libertoski1 insp.
Justin A Boyd1 insp.
Dacia E Quick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.560(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | 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) | 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 Schwabe North America, Inc.'s 3 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