Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-24.
At a glance
Inspections
16
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2025 – 24 Jun 2025 | Human Drugs | 483 | On file |
| 17 Sep 2024 – 23 Sep 2024 | Human Drugs | 483 | On file |
| 24 Apr 2023 – 5 May 2023 | Human Drugs | Clean | |
| 4 Nov 2019 – 8 Nov 2019 | Human Drugs | Clean | |
| 8 Jul 2019 – 16 Jul 2019 | Human Drugs | 483 | On file |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | Clean | |
| 11 May 2017 – 19 May 2017 | Medical Devices & Rad Health | 483 | On file |
| 4 Apr 2016 – 8 Apr 2016 | Human Drugs | Clean | |
| 31 Aug 2015 – 8 Sep 2015 | Human Drugs | Clean | |
| 17 Feb 2014 – 18 Feb 2014 | Human Drugs | 483 | On file |
| 27 Apr 2012 | Not recorded | 483 | On file |
| 29 Jul 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Wayne E Seifert1 insp.
Thuy T Nguyen1 insp.
Cassandra L Abellard1 insp.
Hyung-Yul Lee1 insp.
Alice S Tsao1 insp.
Tonia F Bernard1 insp.
Santos E Camara1 insp.
Laura Fontan1 insp.
Ademola O Daramola1 insp.
Don H Bark1 insp.
Zhongren Wu1 insp.
Joshua P Wireman1 insp.
Zachary A Bogorad1 insp.
Jose A Cruz Gonzalez1 insp.
Christian Lynch1 insp.
Anthony F Lorenzo1 insp.
Jennifer L Schmidt1 insp.
Omotunde O Osunsanmi1 insp.
Mihaly S Ligmond1 insp.
Rose M Ashley1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | 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 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cilag AG's 9 Form 483s
Source PDFs, 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