Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
9
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | On file |
| 20 Feb 2020 – 26 Feb 2020 | Human Drugs | 483 | On file |
| 25 Feb 2019 – 5 Mar 2019 | Human Drugs | 483 | On file |
| 17 Sep 2018 – 21 Sep 2018 | Human Drugs | Clean | |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | 483 | On file |
| 27 Mar 2017 – 3 Apr 2017 | Human Drugs | 483 | On file |
| 16 Aug 2016 – 19 Aug 2016 | Human Drugs | 483 | On file |
| 28 Apr 2014 – 2 May 2014 | Human Drugs | 483 | On file |
| 27 Dec 2006 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Hung H Do1 insp.
Quamrul Majumder1 insp.
Edmund F Mrak1 insp.
Jose M Cayuela1 insp.
Reba A Gates1 insp.
Jennifer C Adams1 insp.
Susanne M Richardson1 insp.
Michael Shanks1 insp.
Scott R Nichols1 insp.
Reyes Candau-Chacon1 insp.
Charanjeet Jassal1 insp.
Luis A Dasta1 insp.
Full site report
Get the verbatim findings behind Biocon Limited's 7 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