Overview
- 19 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-28.
At a glance
Inspections
19
Form 483s
10
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 28 Apr 2026 | Human Drugs | Clean | |
| 14 Aug 2023 – 18 Aug 2023 | Human Drugs | Clean | |
| 18 May 2022 – 26 May 2022 | Human Drugs | 483 | View 483 → |
| 13 Aug 2019 – 15 Aug 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jun 2019 – 25 Jul 2019 | Human Drugs | 483 | View 483 → |
| 19 Mar 2018 – 12 Apr 2018 | Human Drugs | WL | View 483 → |
| 21 Aug 2017 – 25 Aug 2017 | Human Drugs | 483 | On file |
| 7 Nov 2016 – 18 Nov 2016 | Human Drugs | 483 | View 483 → |
| 13 Apr 2015 – 24 Apr 2015 | Human Drugs | 483 | View 483 → |
| 10 Mar 2014 – 21 Mar 2014 | Human Drugs | 483 | View 483 → |
| 2 Feb 2012 | Not recorded | 483 | View 483 → |
| 28 Jul 2011 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2022
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Ko U Min, Johnna L Bleem, Janet A Rajan
26 May 2022
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Ko U Min, Johnna L Bleem, Janet A Rajan
26 May 2022
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Ko U Min, Johnna L Bleem, Janet A Rajan
26 May 2022
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Ko U Min, Johnna L Bleem, Janet A Rajan
26 May 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ko U Min, Johnna L Bleem, Janet A Rajan
Investigators
FDA investigators tied to this site in the record.
Paula J Bretz7 insp.
William A Warnick4 insp.
Ko U Min2 insp.
Rebecca E Dombrowski2 insp.
Atul Agrawal2 insp.
Jonathan W Chapman2 insp.
Pushpa S Jayasekara1 insp.
Anastasia I Onuorah1 insp.
Johnna L Bleem1 insp.
Janet A Rajan1 insp.
Katelyn A Staub-Zamperini1 insp.
Tamil Arasu1 insp.
John P Mistler1 insp.
Guerlain Ulysse1 insp.
Sean R Marcsisin1 insp.
Thomas J Arista1 insp.
James M Mason1 insp.
Melissa T Roy1 insp.
Marcus A Ray1 insp.
Ileana Barreto-Pettit1 insp.
Alison N Stieg1 insp.
Nancy M Espinal1 insp.
Sneha S Patel1 insp.
Kshitij A Patkar1 insp.
Massoud Motamed1 insp.
Pratik S Upadhyay1 insp.
Chaltu N Wakijra1 insp.
Qin Xu1 insp.
Toyin B Oladimeji1 insp.
Brooke K Higgins1 insp.
Ernest Bizjak1 insp.
Rabin N Ghoshal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mylan Pharmaceuticals Inc's 10 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