Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-01-16.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jan 2023 – 16 Jan 2023 | Human Drugs | 483 | On file |
| 19 May 2022 – 27 May 2022 | Human Drugs | 483 | View 483 → |
| 19 Aug 2019 – 27 Aug 2019 | Human Drugs | 483 | View 483 → |
| 27 Mar 2017 – 4 Apr 2017 | Human Drugs | 483 | On file |
| 6 Feb 2015 – 13 Feb 2015 | Human Drugs | WL | View 483 → |
| 26 Aug 2013 – 3 Sep 2013 | Human Drugs | Clean | |
| 25 Jan 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Anastasia M Shields, Jose E Melendez
27 May 2022
21 CFR 211.160(b)(2)
In-process sample representation/identification
Cited by Anastasia M Shields, Jose E Melendez
27 Aug 2019
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jose E Melendez, Kellia N Hicks
27 Aug 2019
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Jose E Melendez, Kellia N Hicks
27 Aug 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jose E Melendez, Kellia N Hicks
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez3 insp.
Justin A Boyd2 insp.
Thuy T Nguyen1 insp.
Anastasia M Shields1 insp.
Kellia N Hicks1 insp.
Robert M Barbosa1 insp.
Paul A Bonneau1 insp.
Jose R Hernandez1 insp.
Carla A Norris1 insp.
Regina T Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 211.63 | 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, 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