Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-27.
At a glance
Inspections
10
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Oct 2022 – 27 Oct 2022 | Human Drugs | 483 | View 483 → |
| 17 Oct 2022 – 26 Oct 2022 | Human Drugs | Clean | |
| 28 Oct 2019 – 1 Nov 2019 | Human Drugs | 483 | View 483 → |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | Clean | |
| 5 Mar 2018 – 20 Mar 2018 | Human Drugs | 483 | View 483 → |
| 1 Jun 2016 – 13 Jun 2016 | Human Drugs | Clean | |
| 19 May 2016 – 20 May 2016 | Human Drugs | Clean | |
| 1 Sep 2000 | Not recorded | Clean | |
| 15 Mar 2000 | Not recorded | Clean | |
| 28 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Nov 2019
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Diane C Van Leeuwen, Mendoza O Wallace
Investigators
FDA investigators tied to this site in the record.
Sherri N Rohlf2 insp.
Diane C Van Leeuwen1 insp.
Mendoza O Wallace1 insp.
Julian C Hanson1 insp.
Michelle J Hines1 insp.
Phal K Chhun1 insp.
Jocelyn E Massey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.60 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Maria Greenwald, MD's 3 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