Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-08.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 May 2026 | Human Drugs | Clean | |
| 11 Apr 2022 – 14 Apr 2022 | Human Drugs | Clean | |
| 14 Oct 2019 – 18 Oct 2019 | Human Drugs | Clean | |
| 8 Nov 2018 – 14 Nov 2018 | Human Drugs | Clean | |
| 10 Jul 2017 – 14 Jul 2017 | Human Drugs | Clean | |
| 1 Aug 2016 – 10 Aug 2016 | Human Drugs | Clean | |
| 11 Aug 2014 – 14 Aug 2014 | Human Drugs | 483 | On file |
| 12 May 2014 – 14 May 2014 | Human Drugs | Clean | |
| 8 May 2014 – 9 May 2014 | Human Drugs | 483 | On file |
| 13 May 2010 | Not recorded | 483 | On file |
| 1 Oct 2009 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Gopa Biswas2 insp.
Jennifer C Adams1 insp.
Kerun Hardeo1 insp.
Richard W Berning1 insp.
Xikui Chen1 insp.
Mohsen Rajabi Abhari1 insp.
Scott B Laufenberg1 insp.
Makini Cobourne-Duval1 insp.
Joanne M Schlossin1 insp.
Parul M Patel1 insp.
Denise L Burosh1 insp.
Kham Phommachanh1 insp.
Paul A Bonneau1 insp.
Michael G Sinkevich1 insp.
Pankaj H Amin1 insp.
Mural B Gavini1 insp.
Full site report
Get the verbatim findings behind Alkem Laboratories Ltd., Bioequivalence Centre's 4 Form 483s
The full inspection record, as Atlas holds it, 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