Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-20.
At a glance
Inspections
13
Form 483s
8
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Mar 2026 – 20 Mar 2026 | Human Drugs | 483 | On file |
| 21 Aug 2023 – 25 Aug 2023 | Human Drugs | Clean | |
| 22 Jan 2019 – 30 Jan 2019 | Human Drugs | Clean | |
| 30 Jul 2018 – 10 Aug 2018 | Human Drugs | 483 | View 483 → |
| 15 May 2017 – 26 May 2017 | Human Drugs | 483 | View 483 → |
| 8 Feb 2016 – 25 Feb 2016 | Human Drugs | 483 | View 483 → |
| 2 Mar 2015 – 6 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jun 2013 – 12 Jul 2013 | Human Drugs | 483 | View 483 → |
| 21 Mar 2012 | Not recorded | 483 | View 483 → |
| 25 Oct 2010 | Not recorded | 483 | View 483 → |
| 30 Oct 2009 | Not recorded | Clean | |
| 18 Dec 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Aug 2018
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Ileana Barreto-Pettit, Latorie S Jones
10 Aug 2018
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Ileana Barreto-Pettit, Latorie S Jones
10 Aug 2018
21 CFR 211.194(a)
Complete test data included in records
Cited by Ileana Barreto-Pettit, Latorie S Jones
10 Aug 2018
21 CFR 211.194(a)(8)
Second person sign off
Cited by Ileana Barreto-Pettit, Latorie S Jones
10 Aug 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ileana Barreto-Pettit, Latorie S Jones
Investigators
FDA investigators tied to this site in the record.
Joanne E King2 insp.
Ileana Barreto-Pettit2 insp.
Michael H Tollon2 insp.
Nicole E Knowlton2 insp.
Santos E Camara1 insp.
Damaris Y Hernandez1 insp.
Mickell Smith1 insp.
Gretchen M Laws1 insp.
Mabany Lizardi1 insp.
Latorie S Jones1 insp.
Jennifer L Huntington1 insp.
Wendy G Tan1 insp.
Ruo H Xu1 insp.
Denise M Digiulio1 insp.
Angela E Glenn1 insp.
Cheryl A Clausen1 insp.
Daryl A Dewoskin1 insp.
Bill Tackett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bausch & Lomb Incorporated's 8 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