Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-12.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2019 – 12 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 18 Dec 2017 – 17 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jan 2015 – 4 Feb 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 May 2007 | Not recorded | Clean | |
| 26 Aug 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jan 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Nydia E Colon, Abby E Pelletier, Laiza V Garcia
17 Jan 2018
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Nydia E Colon, Abby E Pelletier, Laiza V Garcia
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EBI Patient Care, Inc.'s 2 Form 483s
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