Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-28.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Feb 2020 – 28 Feb 2020 | Human Drugs | Clean | |
| 22 Apr 2019 – 26 Apr 2019 | Human Drugs | Clean | |
| 18 May 2017 – 26 May 2017 | Human Drugs | 483 | View 483 → |
| 12 May 2014 – 16 May 2014 | Human Drugs | Clean | |
| 9 Mar 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2017
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Concepcion Cruz, Eric L Dong
26 May 2017
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Concepcion Cruz, Eric L Dong
26 May 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Concepcion Cruz, Eric L Dong
26 May 2017
21 CFR 314.81(b)(1)(ii)
Failure to meet specifications
Cited by Concepcion Cruz, Eric L Dong
Investigators
FDA investigators tied to this site in the record.
Vioela J Caze1 insp.
Joan M Cantellops Figueroa1 insp.
Truong X Nguyen1 insp.
Satheesh K Podaralla1 insp.
Concepcion Cruz1 insp.
Eric L Dong1 insp.
Helen Verdel1 insp.
William A Warnick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | 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 2 Form 483s
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