Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-27.
At a glance
Inspections
11
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2024 – 27 Mar 2024 | Human Drugs | 483 | On file |
| 17 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | View 483 → |
| 19 Aug 2019 – 23 Aug 2019 | Human Drugs | Clean | |
| 13 May 2019 – 17 May 2019 | Human Drugs | 483 | View 483 → |
| 6 Aug 2018 – 10 Aug 2018 | Human Drugs | Clean | |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | On file |
| 2 Mar 2017 – 10 Mar 2017 | Human Drugs | 483 | On file |
| 27 Jul 2015 – 31 Jul 2015 | Human Drugs | 483 | On file |
| 16 Sep 2013 – 20 Sep 2013 | Human Drugs | Clean | |
| 31 Aug 2012 | Not recorded | Clean | |
| 6 Nov 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 May 2019
21 CFR 211.160(b)(2)
Acceptance of in-process materials
Cited by Roger F Zabinski, Alan P Kurtzberg
Investigators
FDA investigators tied to this site in the record.
Nicole E Knowlton3 insp.
Yvins Dezan1 insp.
Jennifer L Huntington1 insp.
Farhana Khan1 insp.
Roger F Zabinski1 insp.
Alan P Kurtzberg1 insp.
Marvin D Jones1 insp.
Scott T Ballard1 insp.
Maria Estrella1 insp.
Qin Xu1 insp.
Pal S Mayasandra1 insp.
Marie F Morin1 insp.
Sangeeta M Khurana1 insp.
Denise M Digiulio1 insp.
Luis A Dasta1 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 | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Alkem 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