Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-14.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2024 – 14 Jun 2024 | Human Drugs | Clean | |
| 12 Sep 2022 – 20 Sep 2022 | Human Drugs | 483 | On file |
| 2 Dec 2019 – 10 Dec 2019 | Human Drugs | 483 | On file |
| 29 Mar 2018 – 6 Apr 2018 | Human Drugs | 483 | View 483 → |
| 1 Dec 2016 – 9 Dec 2016 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2018
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Joey V Quitania, David J Gomes
6 Apr 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joey V Quitania, David J Gomes
Investigators
FDA investigators tied to this site in the record.
MRA V MillarW1 insp.
Susan O Oladeji1 insp.
Dennis Cantellops Paite1 insp.
Joey V Quitania1 insp.
David J Gomes1 insp.
Milva E Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | 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 Tubilux Pharma Spa's 4 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