Overview
- 14 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-05.
At a glance
Inspections
14
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jun 2026 – 5 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 May 2018 – 21 May 2018 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2016 – 28 Oct 2016 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2016 – 29 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 10 Feb 2016 – 2 Mar 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 7 Dec 2015 – 8 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2015 – 24 Feb 2015 | Medical Devices & Rad Health | WL | |
| 6 Oct 2014 – 25 Nov 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Dec 2013 – 16 Dec 2013 | Medical Devices & Rad Health | 483 | On file |
| 14 Jul 2011 | Not recorded | Clean | |
| 18 Feb 2009 | Not recorded | Clean | |
| 13 Jul 2001 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew D Schnittker
5 Jun 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Matthew D Schnittker
8 Jan 2016
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Jacqueline S Warner
8 Jan 2016
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Jacqueline S Warner
Investigators
FDA investigators tied to this site in the record.
Scott R Izyk4 insp.
Jacqueline S Warner3 insp.
Michael G Sinkevich2 insp.
Matthew D Schnittker1 insp.
Gregson A Joseph1 insp.
Satheesh Thomas1 insp.
Meisha A Mandal1 insp.
Catherine M Beer1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind C.R. Bard Inc.'s 5 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