Overview
- 11 FDA inspections are on record.
- 10 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-26.
At a glance
Inspections
11
Form 483s
10
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jul 2024 – 26 Jul 2024 | Human Drugs | 483 | On file |
| 11 Aug 2022 – 26 Aug 2022 | Human Drugs | 483 | On file |
| 22 Aug 2019 – 30 Aug 2019 | Human Drugs | 483 | View 483 → |
| 7 Feb 2019 – 15 Feb 2019 | Human Drugs | 483 | On file |
| 23 Apr 2018 – 1 May 2018 | Human Drugs | 483 | On file |
| 25 May 2017 – 3 Jun 2017 | Human Drugs | 483 | On file |
| 27 Mar 2017 – 7 Apr 2017 | Human Drugs | 483 | On file |
| 19 Oct 2015 – 29 Oct 2015 | Human Drugs | 483 | On file |
| 8 Jun 2015 – 16 Jun 2015 | Human Drugs | 483 | On file |
| 13 Jun 2012 | Not recorded | Clean | |
| 29 Jan 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2019
21 CFR 211.186(b)(7)
Theoretical yield statement including percentages
Cited by Bijoy Panicker
Investigators
FDA investigators tied to this site in the record.
Michael Shanks3 insp.
Justin A Boyd1 insp.
Richard Ledwidge1 insp.
Teresa I Navas1 insp.
Xiaoshi Wang1 insp.
Arsen Karapetyan1 insp.
Zhong Li1 insp.
Ralph M Bernstein1 insp.
Bijoy Panicker1 insp.
Diane L Raccasi1 insp.
Laura Fontan1 insp.
Eileen A Liu1 insp.
Sandra A Hughes1 insp.
Lindsey J Brown1 insp.
Reyes Candau-Chacon1 insp.
Lakshmi Ran Narasimhan1 insp.
Linda F Murphy1 insp.
Joel Martinez1 insp.
S. L Brown1 insp.
Barbara D Paul1 insp.
Regina T Brown1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biocon Biologics Limited's 10 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