Overview
- 33 FDA inspections are on record.
- 19 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-25.
At a glance
Inspections
33
Form 483s
19
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Sep 2024 – 25 Sep 2024 | Biologics | Clean | |
| 28 May 2024 – 6 Jun 2024 | Human Drugs | 483 | View 483 → |
| 24 Aug 2021 – 31 Aug 2021 | Biologics | 483 | On file |
| 1 Mar 2021 – 5 Mar 2021 | Human Drugs | Clean | |
| 15 Jul 2019 – 26 Jul 2019 | Human Drugs | 483 | View 483 → |
| 10 Jun 2019 – 14 Jun 2019 | Biologics | 483 | On file |
| 16 Oct 2018 – 26 Oct 2018 | Biologics | 483 | On file |
| 6 Sep 2017 – 21 Sep 2017 | Human Drugs | 483 | View 483 → |
| 1 Nov 2016 – 16 Nov 2016 | Biologics | 483 | On file |
| 19 Sep 2016 – 30 Sep 2016 | Human Drugs | 483 | On file |
| 27 Jul 2015 – 31 Jul 2015 | Human Drugs | 483 | View 483 → |
| 3 Nov 2014 – 2 Dec 2014 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Jun 2024
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Christopher R Czajka, Roger F Zabinski, Walden H Lee, Michael T Cyrus
6 Jun 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Christopher R Czajka, Roger F Zabinski, Walden H Lee, Michael T Cyrus
6 Jun 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Christopher R Czajka, Roger F Zabinski, Walden H Lee, Michael T Cyrus
26 Jul 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Joey V Quitania, Kristin M Abaonza, Xiomara Copeland
26 Jul 2019
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Joey V Quitania, Kristin M Abaonza, Xiomara Copeland
Investigators
FDA investigators tied to this site in the record.
Heika R Tait6 insp.
Barbara J Breithaupt5 insp.
Mihaly S Ligmond3 insp.
Sangeeta M Khurana2 insp.
Gloria J Baca2 insp.
Prabhu P Raju2 insp.
Lynda L Perry2 insp.
Marijo B Kambere2 insp.
Eileen A Liu2 insp.
Rebecca Rodriguez2 insp.
Anita Narula2 insp.
Caryn M Mcnab2 insp.
Kari M Johansen2 insp.
Shafiq Ahadi1 insp.
Lewis K Antwi1 insp.
Christopher R Czajka1 insp.
Roger F Zabinski1 insp.
Walden H Lee1 insp.
Michael T Cyrus1 insp.
Jacqueline M Diaz Albert1 insp.
Laurel A Beer1 insp.
Jacqueline M Diaz Albertini1 insp.
Kenneth O Gee1 insp.
Joey V Quitania1 insp.
Kristin M Abaonza1 insp.
Xiomara Copeland1 insp.
Bradley J Dworak1 insp.
Christine Harman1 insp.
Uttaniti Limchumroon1 insp.
Tracy K Li1 insp.
Ashar P Parikh1 insp.
Don H Bark1 insp.
Gerard P De Leon1 insp.
Debra M Emerson1 insp.
Omotunde O Osunsanmi1 insp.
Mark W Babbitt1 insp.
Andrew J Idzior1 insp.
Robert D Tollefsen1 insp.
Alexander M Kay1 insp.
Paula A Trost1 insp.
Maria P Kelly-Doggett1 insp.
Maxine H Wong1 insp.
Randy L Self1 insp.
S. L Brown1 insp.
Christian Lynch1 insp.
Mikel T Wright1 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 | 5x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(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 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Jubilant HollisterStier LLC's 19 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