Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-22.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Oct 2024 – 22 Oct 2024 | Human Drugs | Clean | |
| 6 May 2024 – 17 May 2024 | Human Drugs | 483 | View 483 → |
| 15 Sep 2022 – 23 Sep 2022 | Human Drugs | 483 | View 483 → |
| 6 Sep 2021 – 17 Sep 2021 | Human Drugs | 483 | View 483 → |
| 16 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 8 May 2017 – 15 May 2017 | Human Drugs | 483 | View 483 → |
| 5 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | On file |
| 10 Mar 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Patty P Kaewussdangkul, Kevin P Regan
17 May 2024
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Patty P Kaewussdangkul, Kevin P Regan
17 May 2024
21 CFR 211.192
No written record of investigation
Cited by Patty P Kaewussdangkul, Kevin P Regan
17 May 2024
21 CFR 314.81(b)(1)(ii)
Failure to meet specifications
Cited by Patty P Kaewussdangkul, Kevin P Regan
Investigators
FDA investigators tied to this site in the record.
Junho Pak1 insp.
Patty P Kaewussdangkul1 insp.
Kevin P Regan1 insp.
Thomas J Arista1 insp.
Dipesh K Shah1 insp.
Rita K Kabaso1 insp.
Anastasia M Shields1 insp.
Jose E Melendez1 insp.
Michael A Charles1 insp.
Jose R Hernandez1 insp.
John A Gonzalez1 insp.
David J Gomes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | 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)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mylan Laboratories Limited's 6 Form 483s
Source PDFs 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