Overview
- 19 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-18.
At a glance
Inspections
19
Form 483s
8
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Jul 2025 – 18 Jul 2025 | Biologics | 483 | On file |
| 2 Dec 2024 – 6 Dec 2024 | Human Drugs | 483 | View 483 → |
| 3 Sep 2024 – 6 Sep 2024 | Human Drugs | Clean | |
| 29 Jan 2024 – 31 Jan 2024 | Human Drugs | Clean | |
| 5 Jun 2023 – 16 Jun 2023 | Biologics | 483 | View 483 → |
| 7 Mar 2022 – 14 Mar 2022 | Human Drugs | Clean | |
| 15 Feb 2021 – 19 Feb 2021 | Biologics | 483 | On file |
| 26 May 2020 – 3 Jun 2020 | Human Drugs | Clean | |
| 8 Jul 2019 – 26 Jul 2019 | Human Drugs | Clean | |
| 25 Jun 2018 – 27 Jun 2018 | Human Drugs | Clean | |
| 13 Mar 2017 – 17 Mar 2017 | Human Drugs | Clean | |
| 19 Dec 2016 – 25 Jan 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2024
FDCA 505-1(f)(3)(A)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
Cited by Tyanna N Hadley
6 Dec 2024
FDCA 505-1(f)(3)(B)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
Cited by Tyanna N Hadley
6 Dec 2024
FDCA 505-1(f)(3)(E)
Failure to comply with REMS Elements to Assure Safe Use (ETASU) E
Cited by Tyanna N Hadley
16 Jun 2023
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Unnee Ranjan, Helen B Ricalde, Emily A Walters
Investigators
FDA investigators tied to this site in the record.
Michael Serrano4 insp.
Tyanna N Hadley2 insp.
Alberto A Viciedo2 insp.
Massoud Motamed1 insp.
Christian Lynch1 insp.
Elvira R Argus1 insp.
Jay B Shah1 insp.
Byungja E Marciante1 insp.
Unnee Ranjan1 insp.
Helen B Ricalde1 insp.
Emily A Walters1 insp.
Linda Thai1 insp.
Nimmy Mathews1 insp.
Kimberly L Schultz1 insp.
Nina Yang1 insp.
Ruth A Williams1 insp.
Peter R Lenahan1 insp.
Melissa T Roy1 insp.
Jose M Cayuela1 insp.
Justine Tomasso1 insp.
Dorothy J Denes1 insp.
Erin D Mccaffery1 insp.
Nicholas A Violand1 insp.
Addam S Reynolds1 insp.
Dawn L Wydner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(B) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(E) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Celgene Corporation's 8 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