Overview
- 8 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-09-13.
At a glance
Inspections
8
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Sep 2024 | Biologics | Clean | |
| 21 Sep 2021 | Biologics | Clean | |
| 7 Jun 2018 – 12 Jun 2018 | Biologics | Clean | |
| 27 Oct 2016 – 31 Oct 2016 | Biologics | Clean | |
| 6 Oct 2014 – 10 Oct 2014 | Biologics | Clean | |
| 18 Jun 2013 – 24 Jun 2013 | Biologics | 483 | View 483 → |
| 8 Jun 2011 | Not recorded | Clean | |
| 15 May 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2013
21 CFR 1271.55(a)(2)
Eligibility statement--basis of determination
Cited by Denise M Visco, Jonee J Mearns
24 Jun 2013
21 CFR 1271.55(a)(3)
Summary--records used to make determination
Cited by Denise M Visco, Jonee J Mearns
24 Jun 2013
21 CFR 1271.65(a)
Improper release prevention--storage, I.D.
Cited by Denise M Visco, Jonee J Mearns
Investigators
FDA investigators tied to this site in the record.
Sarah M Forney3 insp.
Denise M Visco2 insp.
Jonee J Mearns2 insp.
Charles D Boison1 insp.
Jennifer Macmillan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Reproductive Center Of Central New Jersey'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