Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-10.
At a glance
Inspections
3
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 10 Oct 2025 | Human Drugs | 483 | View 483 → |
| 24 Jan 2022 – 2 Feb 2022 | Human Drugs | 483 | On file |
| 25 Aug 2020 – 8 Sep 2020 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2025
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Andrew O Ejiofor
8 Sep 2020
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Yvins Dezan, Annet R Rajan
8 Sep 2020
21 CFR 211.68(b)
Computer control of master formula records
Cited by Yvins Dezan, Annet R Rajan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biocon Generics Inc.'s 3 Form 483s
Source PDFs 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