Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-05-23.
At a glance
Inspections
10
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 May 2013 – 23 May 2013 | Human Drugs | 483 | View 483 → |
| 22 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 16 Feb 2012 | Not recorded | Clean | |
| 25 Feb 2011 | Not recorded | Clean | |
| 14 Jan 2011 | Not recorded | 483 | View 483 → |
| 11 May 2010 | Not recorded | Clean | |
| 17 Sep 2009 | Not recorded | Clean | |
| 8 Jul 2009 | Not recorded | Clean | |
| 26 Apr 2006 | Not recorded | Clean | |
| 9 Aug 2004 | 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.
Jeffrey M Watson2 insp.
Ashar P Parikh1 insp.
Sergio Chavez1 insp.
Alla Dubrovsky1 insp.
Lance M De Souza1 insp.
Rochelle B Young1 insp.
Lorna F Jones1 insp.
Gina M Hall1 insp.
Italia Nappi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mylan Specialty, L.P.'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