Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-12.
At a glance
Inspections
8
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2024 – 12 Apr 2024 | Human Drugs | 483 | View 483 → |
| 21 Oct 2015 – 26 Oct 2015 | Human Drugs | Clean | |
| 14 Feb 2013 – 28 Feb 2013 | Human Drugs | Clean | |
| 10 Feb 2012 | Not recorded | 483 | View 483 → |
| 4 Nov 2010 | Not recorded | Clean | |
| 8 Oct 2010 | Not recorded | Clean | |
| 10 Dec 2009 | Not recorded | Clean | |
| 24 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Claudia M Perez-Kasmarski, Navneet Kaur
Investigators
FDA investigators tied to this site in the record.
Jeffrey M Watson2 insp.
Claudia M Perez-Kasmarski1 insp.
Navneet Kaur1 insp.
Anh Lac1 insp.
Sandra S Saniga1 insp.
William V Millar1 insp.
Peter E Baker1 insp.
Andrew P Lin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bausch Health Americas, Inc.'s 2 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