Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-02-08.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Dec 2018 – 8 Feb 2019 | Human Drugs | WL | View 483 → |
| 5 Jul 2016 – 6 Jul 2016 | Human Drugs | 483 | On file |
| 3 Sep 2014 – 5 Sep 2014 | Human Drugs | 483 | View 483 → |
| 7 Sep 2012 | Not recorded | 483 | View 483 → |
| 3 Dec 2008 | Not recorded | 483 | View 483 → |
| 16 Jan 2008 | Not recorded | 483 | On file |
| 20 Nov 2006 | Not recorded | Clean | |
| 1 Dec 2005 | Not recorded | Clean | |
| 13 May 2005 | Not recorded | Clean | |
| 11 Mar 2003 | Not recorded | Clean | |
| 21 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
David A Oluwo1 insp.
Luis A Dasta1 insp.
Alison N Correll1 insp.
Derek S Dealy1 insp.
Craig D Zagata1 insp.
Matthew R Noonan1 insp.
Julianne C Mccullough1 insp.
Vlada Matusovsky1 insp.
Anita R Michael1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | 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