Overview
- 15 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-02.
At a glance
Inspections
15
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Nov 2022 – 2 Dec 2022 | Biologics | Clean | |
| 11 Sep 2017 – 20 Sep 2017 | Biologics | Clean | |
| 17 Sep 2015 – 9 Oct 2015 | Biologics | Clean | |
| 16 Sep 2015 – 30 Sep 2015 | Biologics | Clean | |
| 23 Oct 2014 | Biologics | Clean | |
| 15 Oct 2014 – 16 Oct 2014 | Biologics | Clean | |
| 27 May 2014 – 17 Jun 2014 | Biologics | 483 | On file |
| 1 Aug 2012 | Not recorded | 483 | View 483 → |
| 4 Nov 2010 | Not recorded | Clean | |
| 4 Jun 2010 | Not recorded | 483 | On file |
| 29 Jul 2008 | Not recorded | 483 | On file |
| 14 Mar 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover
1 Aug 2012
21 CFR 606.100(c)
Thorough investigations
Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover
1 Aug 2012
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Nikisha M Bolden, Gayle S Lawson, Megan M Lauff, Linda M Hoover
Investigators
FDA investigators tied to this site in the record.
Gayle S Lawson7 insp.
Nikisha M Bolden5 insp.
Erika M Wilkerson3 insp.
Michele M Falchek3 insp.
Craig D Zagata2 insp.
Anastasia M Shields2 insp.
Kimberly A Dux2 insp.
Kish Bolden1 insp.
Emily A Walters1 insp.
Bradley E Benasutti1 insp.
Edwin L Hobbs1 insp.
Daniel W Johnson1 insp.
Megan M Lauff1 insp.
Linda M Hoover1 insp.
John M Mastalski1 insp.
Ann-Marie Karnick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American National Red Cross, Penn Jersey Region'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