Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-08-27.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2014 – 27 Aug 2014 | Biologics | Clean | |
| 11 Apr 2013 – 30 Apr 2013 | Biologics | 483 | View 483 → |
| 21 Jul 2011 | Not recorded | 483 | View 483 → |
| 22 Jul 2010 | Not recorded | Clean | |
| 18 Jul 2009 | Not recorded | Clean | |
| 24 Jan 2008 | Not recorded | Clean | |
| 17 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Apr 2013
21 CFR 606.100(b)(7)
Methods for performance of all tests
Cited by Nikisha M Bolden, Gayle S Lawson
30 Apr 2013
21 CFR 606.140(a)
Establishment of spec., standards, and test procedures
Cited by Nikisha M Bolden, Gayle S Lawson
21 Jul 2011
21 CFR 606.160(d)
Retention period
Cited by Nikisha M Bolden, Michele M Falchek, Linda M Hoover
Investigators
FDA investigators tied to this site in the record.
Michele M Falchek4 insp.
Linda M Hoover3 insp.
Nikisha M Bolden2 insp.
Dawn D Aiello2 insp.
Bradley E Benasutti1 insp.
Kimberly A Dux1 insp.
Gayle S Lawson1 insp.
Stephanie C Mangigian1 insp.
Julianne C Mccullough1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.140(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site'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