Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-10.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jan 2025 – 10 Jan 2025 | Human Drugs | Clean | |
| 28 Oct 2019 – 31 Oct 2019 | Human Drugs | Clean | |
| 19 Jun 2017 – 23 Jun 2017 | Human Drugs | 483 | View 483 → |
| 14 Sep 2015 – 18 Sep 2015 | Human Drugs | 483 | View 483 → |
| 13 Sep 2013 – 19 Sep 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Sep 2015
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Samina S Khan, Charanjeet Jassal
Investigators
FDA investigators tied to this site in the record.
MRA M BarbosaR1 insp.
MRA McCulloughJ1 insp.
Satheesh Thomas1 insp.
Samina S Khan1 insp.
Charanjeet Jassal1 insp.
Michael H Tollon1 insp.
Sarah E Mcmullen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Opella Healthcare International SAS' 3 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