Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-05-31.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 May 2018 – 31 May 2018 | Biologics | Clean | |
| 21 Mar 2016 – 22 Mar 2016 | Biologics | Clean | |
| 11 Mar 2014 – 21 Mar 2014 | Biologics | 483 | View 483 → |
| 7 Mar 2012 | Not recorded | 483 | View 483 → |
| 2 Nov 2010 | Not recorded | Clean | |
| 22 Jan 2009 | Not recorded | Clean | |
| 14 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Susan M Miller4 insp.
Susan M North1 insp.
Melanie C Voges1 insp.
Kellie L Westerbuhr1 insp.
Ellen C Weisensel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind RTI Donor Services' 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