Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-10-08.
At a glance
Inspections
5
Form 483s
1
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 23 May 2016 – 10 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 11 Mar 2013 – 15 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 17 May 2012 | Not recorded | 483 | View 483 → |
| 19 Sep 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2012
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.40(a)
Not approved or obsolete document retrieval
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(a)
Nonconforming product control
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
17 May 2012
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Shafiq Ahadi, Steven D Kehoe, Mary K Concannon, Matthew H Hunt
Investigators
FDA investigators tied to this site in the record.
Shafiq Ahadi2 insp.
Edward E Lockwood1 insp.
Eric M Padgett1 insp.
Dustin K Hampton1 insp.
Thuy T Nguyen1 insp.
James D Planchon1 insp.
Steven D Kehoe1 insp.
Mary K Concannon1 insp.
Matthew H Hunt1 insp.
William C Corley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | 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 & Lomb Inc's 1 Form 483
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