Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-10-10.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2017 – 10 Oct 2017 | Human Drugs | WL | View 483 → |
| 30 Jan 2014 – 6 Mar 2014 | Human Drugs | 483 | On file |
| 13 Dec 2012 | Not recorded | 483 | On file |
| 21 May 2009 | Not recorded | 483 | View 483 → |
| 3 May 2007 | Not recorded | Clean | |
| 29 Oct 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Christina A Miller, Philip F Istafanos
10 Oct 2017
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Christina A Miller, Philip F Istafanos
10 Oct 2017
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Christina A Miller, Philip F Istafanos
10 Oct 2017
21 CFR 211.194(a)
Complete test data included in records
Cited by Christina A Miller, Philip F Istafanos
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 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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