Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-17.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2023 – 17 Nov 2023 | Human Drugs | 483 | View 483 → |
| 6 Mar 2023 – 9 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 27 Mar 2017 – 29 Mar 2017 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Nov 2023
21 CFR 211.122(d)
Label storage access limited to authorized personnel
Cited by Alan P Kurtzberg
17 Nov 2023
21 CFR 211.166(a)(2)
Stability sample storage conditions described
Cited by Alan P Kurtzberg
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 211.122(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Laboratorios Zepol S.A.'s 2 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