Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-11-08.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Nov 2022 | Biologics | Clean | |
| 13 Aug 2018 – 15 Aug 2018 | Biologics | 483 | View 483 → |
| 11 Apr 2016 | Biologics | Clean | |
| 13 Jun 2014 | Biologics | Clean | |
| 12 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Aug 2018
21 CFR 1271.90(c)
Eligibility not required--warning labels
Cited by Uruaku A Obasi, Neali H Lucas
15 Aug 2018
21 CFR 1271.90(c)
Eligibility not required--warning labels
Cited by Uruaku A Obasi, Neali H Lucas
Investigators
FDA investigators tied to this site in the record.
John A Iwen1 insp.
Uruaku A Obasi1 insp.
Neali H Lucas1 insp.
Brentley S Collins1 insp.
Jennifer C Adams1 insp.
Jennifer C Johnson1 insp.
Laurie A Haxel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Carle Reproductive Medicine's 1 Form 483
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