Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-07.
At a glance
Inspections
8
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2024 – 7 Nov 2024 | Human Drugs | 483 | View 483 → |
| 27 Mar 2024 – 18 Apr 2024 | Foods & Cosmetics | Clean | |
| 15 Jun 2021 – 16 Jun 2021 | Human Drugs | 483 | View 483 → |
| 13 May 2019 – 16 May 2019 | Human Drugs | Clean | |
| 27 Feb 2018 – 28 Feb 2018 | Human Drugs | Clean | |
| 2 May 2016 – 17 May 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 May 2014 – 19 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Dec 2013 – 24 Dec 2013 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Nov 2024
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Michael Serrano, Jose A Torres, Meredith L Miller
16 Jun 2021
FDCA 505-1(f)(4)
Failure to comply with REMS Implementation System
Cited by Michael Serrano
17 May 2016
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by David H Smith, Michael Serrano, Richard A Abate
17 May 2016
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by David H Smith, Michael Serrano, Richard A Abate
17 May 2016
21 CFR 314.80(j)
Failure to maintain records
Cited by David H Smith, Michael Serrano, Richard A Abate
Investigators
FDA investigators tied to this site in the record.
Michael Serrano5 insp.
Jose A Torres1 insp.
Meredith L Miller1 insp.
Spiridoula Dimopoulos1 insp.
Diane B Radice1 insp.
Namita Kothary1 insp.
David H Smith1 insp.
Richard A Abate1 insp.
Jonee J Mearns1 insp.
Stephen J Mottola1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.56(b) | Cited across public-safe Form 483 observations | 2x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 312.57(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bausch Health US., 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