Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-09-02.
At a glance
Inspections
5
Form 483s
1
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Aug 2016 – 2 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Apr 2014 – 18 Apr 2014 | Medical Devices & Rad Health | Clean | |
| 7 Aug 2009 | Not recorded | Clean | |
| 17 Nov 2004 | Not recorded | Clean | |
| 22 Jul 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Marcus A Ray, Chaltu N Wakijra
2 Sep 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Marcus A Ray, Chaltu N Wakijra
2 Sep 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marcus A Ray, Chaltu N Wakijra
2 Sep 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Marcus A Ray, Chaltu N Wakijra
2 Sep 2016
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Marcus A Ray, Chaltu N Wakijra
Investigators
FDA investigators tied to this site in the record.
Marcus A Ray1 insp.
Chaltu N Wakijra1 insp.
Nebil A Oumer1 insp.
Patric C Klotzbuecher1 insp.
Lakisha M Williams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Aplicare Incorporated'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