Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-21.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2025 – 21 Feb 2025 | Human Drugs | 483 | View 483 → |
| 8 Feb 2019 – 14 Feb 2019 | Human Drugs | 483 | On file |
| 13 Feb 2017 – 22 Feb 2017 | Human Drugs | 483 | View 483 → |
| 21 Jan 2014 – 23 Jan 2014 | Human Drugs | 483 | On file |
| 9 Dec 2011 | Not recorded | 483 | On file |
| 30 Jun 2009 | Not recorded | 483 | On file |
| 15 Jun 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2025
21 CFR 211.115(a)
Reprocessing procedures not written or followed
Cited by Dorothy P Kramer
Investigators
FDA investigators tied to this site in the record.
Dorothy P Kramer1 insp.
Veronica Fuentes1 insp.
Steven J Rush1 insp.
Susan O Oladeji1 insp.
Johnetta F Walters1 insp.
Jawaid Hamid1 insp.
Tamika D Cathey1 insp.
Hai Lien T Phung1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 6 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