Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-30.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2019 – 30 May 2019 | Biologics | 483 | View 483 → |
| 4 May 2017 | Biologics | Clean | |
| 11 Mar 2015 | Biologics | Clean | |
| 7 Nov 2012 | Not recorded | Clean | |
| 25 Jan 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Ensurane of compliance
Cited by Lura D Baquero, Samantha J Pinizzotto
Ensurane of compliance
Cited by Lura D Baquero, Samantha J Pinizzotto
Donor eligibility procedures
Cited by Lura D Baquero, Samantha J Pinizzotto
Donor eligibility procedures
Cited by Lura D Baquero, Samantha J Pinizzotto
Determination based on screening and testing
Cited by Lura D Baquero, Samantha J Pinizzotto
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 1271.47(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1271.150(c)(1)(iii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Reproductive Medicine Institute IVF, LLC's 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