Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-11.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Sep 2024 – 11 Sep 2024 | Medical Devices & Rad Health | Clean | |
| 22 Jan 2018 – 2 Feb 2018 | Medical Devices & Rad Health | Clean | |
| 8 May 2017 – 10 May 2017 | Medical Devices & Rad Health | Clean | |
| 23 Aug 2016 – 1 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jun 2015 – 28 Jul 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Jun 2014 – 26 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew D Schnittker, Nicholas C Mendiola
1 Sep 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew D Schnittker, Nicholas C Mendiola
1 Sep 2016
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by Matthew D Schnittker, Nicholas C Mendiola
Investigators
FDA investigators tied to this site in the record.
Matthew D Schnittker2 insp.
Nicholas C Mendiola2 insp.
Frank J Marciniak2 insp.
William R Chang1 insp.
Harry J Brewer1 insp.
Jennifer L Custodio1 insp.
Doreen P Gubbay1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.166(a)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.184(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bausch Health Americas, 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