Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-09-11.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Sep 2018 | Biologics | Clean | |
| 11 Apr 2016 – 13 Apr 2016 | Biologics | Clean | |
| 27 Feb 2014 – 3 Mar 2014 | Biologics | 483 | On file |
| 14 Jan 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jan 2011
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Sherri J Jackson, L'Oreal F Walker
14 Jan 2011
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Sherri J Jackson, L'Oreal F Walker
14 Jan 2011
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Sherri J Jackson, L'Oreal F Walker
14 Jan 2011
21 CFR 1271.55(d)(2)
Accurate, indelible, legible
Cited by Sherri J Jackson, L'Oreal F Walker
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz1 insp.
Crystal M Young-Lewis1 insp.
Neali H Lucas1 insp.
Sherri J Jackson1 insp.
L'Oreal F Walker1 insp.
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 | 1x |
| 21 CFR 1271.50(b)(2) | 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 1271.55(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advanced Reproductive Medicine & Surgery, P.C.'s 2 Form 483s
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