Overview
- 17 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
17
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 19 Sep 2025 | Human Drugs | 483 | View 483 → |
| 13 Jun 2022 – 15 Jun 2022 | Human Drugs | Clean | |
| 9 Mar 2020 – 11 Mar 2020 | Human Drugs | Clean | |
| 3 Jun 2019 – 6 Jun 2019 | Human Drugs | Clean | |
| 9 Jul 2018 – 13 Jul 2018 | Human Drugs | Clean | |
| 8 Apr 2015 – 9 Apr 2015 | Human Drugs | Clean | |
| 6 May 2014 – 7 May 2014 | Human Drugs | Clean | |
| 14 Jan 2014 – 14 Feb 2014 | Human Drugs | 483 | On file |
| 10 Aug 2012 | Not recorded | Clean | |
| 9 Jun 2011 | Not recorded | Clean | |
| 15 Apr 2010 | Not recorded | Clean | |
| 3 Sep 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Penny H Mccarver4 insp.
Eileen J Bannerman3 insp.
Veronica Fuentes2 insp.
Adam R Cooke2 insp.
Tracy R Ball2 insp.
Samantha E Cleek1 insp.
Gideon N Esuzor1 insp.
Jared P Stevens1 insp.
Daphne Santiago1 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 | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Generics Bidco II LLC's 2 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