Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
12
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 26 Mar 2026 | Human Drugs | 483 | View 483 → |
| 13 May 2024 – 21 May 2024 | Medical Devices & Rad Health | Clean | |
| 10 Dec 2018 – 14 Dec 2018 | Human Drugs | 483 | View 483 → |
| 4 Jan 2016 – 8 Jan 2016 | Medical Devices & Rad Health | Clean | |
| 3 Dec 2013 – 6 Dec 2013 | Human Drugs | Clean | |
| 14 Jun 2012 | Not recorded | Clean | |
| 18 Jun 2010 | Not recorded | Clean | |
| 26 Mar 2009 | Not recorded | Clean | |
| 25 Apr 2005 | Not recorded | Clean | |
| 24 Sep 2003 | Not recorded | Clean | |
| 4 Aug 2002 | Not recorded | Clean | |
| 22 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Shanna N Purdy, Demario L Walls
26 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Shanna N Purdy, Demario L Walls
26 Mar 2026
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Shanna N Purdy, Demario L Walls
14 Dec 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Erika V Butler
Investigators
FDA investigators tied to this site in the record.
James R Montero2 insp.
Shanna N Purdy1 insp.
Demario L Walls1 insp.
Nga T Ho1 insp.
Erika V Butler1 insp.
Edith M Gonzalez1 insp.
Zachery L Miller1 insp.
Janet Pulver1 insp.
Debra L Curtis1 insp.
Marion W Nadeau1 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 | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Becton Dickinson Infusion Therapy Systems, 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