Overview
- 13 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-03.
At a glance
Inspections
13
Form 483s
8
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2025 – 3 Nov 2025 | Human Drugs | WL | View 483 → |
| 3 Jun 2024 – 14 Jun 2024 | Human Drugs | 483 | On file |
| 20 Feb 2023 – 28 Feb 2023 | Human Drugs | 483 | View 483 → |
| 3 Oct 2022 – 7 Oct 2022 | Human Drugs | Clean | |
| 24 May 2018 – 1 Jun 2018 | Human Drugs | WL | View 483 → |
| 28 Nov 2016 – 13 Dec 2016 | Human Drugs | 483 | On file |
| 30 Nov 2015 – 10 Dec 2015 | Human Drugs | 483 | View 483 → |
| 18 Sep 2013 – 26 Sep 2013 | Human Drugs | 483 | View 483 → |
| 26 Mar 2012 | Not recorded | WL | On file |
| 11 Feb 2010 | Not recorded | Clean | |
| 5 Feb 2009 | Not recorded | Clean | |
| 22 Jan 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Nov 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jeffrey P Raimondi, Unnee Ranjan
3 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jeffrey P Raimondi, Unnee Ranjan
3 Nov 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jeffrey P Raimondi, Unnee Ranjan
3 Nov 2025
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Jeffrey P Raimondi, Unnee Ranjan
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Unnee Ranjan1 insp.
Jose E Melendez1 insp.
Philip F Istafanos1 insp.
Crystal Monroy1 insp.
Rafeeq A Habeeb1 insp.
Logan T Williams1 insp.
Alanna L Mussawwir Bias1 insp.
Brett R Havranek1 insp.
Jamie L Dion1 insp.
Claire M Minden1 insp.
Christopher T Middendorf1 insp.
Omotunde O Osunsanmi1 insp.
Rebecca Rodriguez1 insp.
Carla A Norris1 insp.
Stephen D Brown1 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 | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | 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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Jubilant HollisterStier General Partnership'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