Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-24.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 24 May 2024 | Human Drugs | 483 | On file |
| 3 Feb 2020 – 7 Feb 2020 | Human Drugs | 483 | On file |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | 483 | On file |
| 5 Apr 2018 – 12 Apr 2018 | Human Drugs | 483 | On file |
| 5 Sep 2016 – 14 Sep 2016 | Human Drugs | WL | On file |
| 19 Mar 2015 – 25 Mar 2015 | Human Drugs | 483 | On file |
| 30 Aug 2012 | Not recorded | Clean | |
| 27 May 2011 | Not recorded | 483 | On file |
| 8 Aug 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 May 2024
21 CFR 211.167(c)
Controlled release test methods written, followed
Cited by Wayne D Mcgrath, Arsen Karapetyan
24 May 2024
21 CFR 211.180(c)
Records not made readily available to FDA
Cited by Wayne D Mcgrath, Arsen Karapetyan
24 May 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wayne D Mcgrath, Arsen Karapetyan
24 May 2024
21 CFR 211.192
Written record of investigation incomplete
Cited by Wayne D Mcgrath, Arsen Karapetyan
24 May 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wayne D Mcgrath, Arsen Karapetyan
Investigators
FDA investigators tied to this site in the record.
Kellia N Hicks2 insp.
Wayne D Mcgrath1 insp.
Arsen Karapetyan1 insp.
Dipesh K Shah1 insp.
Jose E Melendez1 insp.
Massoud Motamed1 insp.
Eric M Mueller1 insp.
Rafael E Arroyo1 insp.
Simone E Pitts1 insp.
Susanna E Ford1 insp.
Atul Agrawal1 insp.
Mural B Gavini1 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 | 10x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 2x |
| 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 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.95(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(c) | 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 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mylan Laboratories Limited's 7 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