Overview
- 9 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-24.
At a glance
Inspections
9
Form 483s
8
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Feb 2023 – 24 Feb 2023 | Human Drugs | Clean | |
| 9 Jan 2023 – 16 Jan 2023 | Human Drugs | 483 | On file |
| 20 Feb 2020 – 28 Feb 2020 | Human Drugs | 483 | View 483 → |
| 6 May 2019 – 13 May 2019 | Human Drugs | 483 | View 483 → |
| 22 Feb 2018 – 2 Mar 2018 | Human Drugs | 483 | View 483 → |
| 10 Apr 2017 – 18 Apr 2017 | Human Drugs | 483 | View 483 → |
| 4 Apr 2016 – 13 Apr 2016 | Human Drugs | 483 | On file |
| 23 Sep 2014 – 3 Oct 2014 | Human Drugs | WL | On file |
| 17 Jun 2013 – 27 Jun 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2020
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Linda F Murphy, Steven M Weinman
28 Feb 2020
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Linda F Murphy, Steven M Weinman
28 Feb 2020
21 CFR 211.192
Written record of investigation incomplete
Cited by Linda F Murphy, Steven M Weinman
28 Feb 2020
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Linda F Murphy, Steven M Weinman
28 Feb 2020
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Linda F Murphy, Steven M Weinman
Investigators
FDA investigators tied to this site in the record.
Thomas J Arista2 insp.
Joanne E King1 insp.
Justin A Boyd1 insp.
Thuy T Nguyen1 insp.
Linda F Murphy1 insp.
Steven M Weinman1 insp.
Dipesh K Shah1 insp.
Yasamin Ameri1 insp.
Saleem A Akhtar1 insp.
Scott T Ballard1 insp.
Jose E Melendez1 insp.
Parul M Patel1 insp.
Harry J Brewer1 insp.
Peter E Baker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | 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 8 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