Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-16.
At a glance
Inspections
12
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2024 – 16 Dec 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Dec 2022 – 19 Dec 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2022 – 31 Mar 2022 | Human Drugs | 483 | View 483 → |
| 4 Dec 2019 – 12 Dec 2019 | Human Drugs | Clean | |
| 26 Sep 2018 – 28 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jun 2015 – 4 Jun 2015 | Human Drugs | Clean | |
| 1 Mar 2011 | Not recorded | Clean | |
| 11 Jun 2010 | Not recorded | Clean | |
| 27 Jul 2009 | Not recorded | Clean | |
| 4 Sep 2008 | Not recorded | 483 | On file |
| 27 Jun 2006 | Not recorded | Clean | |
| 16 Jan 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Roy Baby, Elizabeth A Krolczyk
16 Dec 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Roy Baby, Elizabeth A Krolczyk
16 Dec 2024
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk
16 Dec 2024
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Roy Baby, Elizabeth A Krolczyk
Investigators
FDA investigators tied to this site in the record.
Roy Baby1 insp.
Elizabeth A Krolczyk1 insp.
Terri E Gibson1 insp.
Patty P Kaewussdangkul1 insp.
Shanna N Purdy1 insp.
Jessica M Simpson1 insp.
Lisa R Whitt1 insp.
Jude C Dike1 insp.
Shawn E Larson1 insp.
Patrice S Hall1 insp.
Anh Lac1 insp.
Akbar J Zaidi1 insp.
Jodi M Gatica1 insp.
Jeffrey R Wooley1 insp.
Elisa M Fleming1 insp.
Trina K Vick1 insp.
Margaret M Annes1 insp.
Lauren E Skokan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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 211.42(c)(2) | 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 Swiss-American CDMO, LLC's 5 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