Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-22.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2023 – 22 Mar 2023 | Human Drugs | 483 | On file |
| 9 May 2022 – 12 May 2022 | Medical Devices & Rad Health | 483 | On file |
| 1 Jul 2019 – 5 Jul 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jul 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bryan A Galvez
5 Jul 2019
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Bryan A Galvez
5 Jul 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bryan A Galvez
Investigators
FDA investigators tied to this site in the record.
David A Oluwo1 insp.
Freddy Ortiz Colon1 insp.
Lisa Shin1 insp.
Stephen D Eich1 insp.
Bryan A Galvez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Ivers-Lee SA's 3 Form 483s
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