Overview
- 23 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-06.
At a glance
Inspections
23
Form 483s
16
EIRs
8
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Dec 2024 – 6 Dec 2024 | Human Drugs | 483 | View 483 → |
| 10 May 2022 – 14 Nov 2022 | Human Drugs | 483 | On file |
| 26 Jul 2021 – 29 Sep 2021 | Human Drugs | 483 | On file |
| 19 Oct 2020 – 30 Oct 2020 | Human Drugs | 483 | View 483 → |
| 6 Jul 2020 – 10 Jul 2020 | Human Drugs | 483 | View 483 → |
| 23 Oct 2018 – 9 Nov 2018 | Human Drugs | 483 | View 483 → |
| 6 Nov 2017 – 16 Nov 2017 | Human Drugs | 483 | View 483 → |
| 13 Mar 2017 – 24 Mar 2017 | Human Drugs | 483 | View 483 → |
| 22 Feb 2016 – 18 Mar 2016 | Human Drugs | 483 | View 483 → |
| 11 May 2015 – 22 May 2015 | Human Drugs | 483 | View 483 → |
| 19 Feb 2014 – 26 Feb 2014 | Human Drugs | 483 | On file |
| 7 May 2013 – 22 May 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Dec 2024
21 CFR 211.160(b)(4)
Establishment of calibration procedures
Cited by David A Oluwo, Lu Chen, Young K Chou
6 Dec 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by David A Oluwo, Lu Chen, Young K Chou
6 Dec 2024
21 CFR 211.67(b)(3)
Cleaning SOPs/instructions
Cited by David A Oluwo, Lu Chen, Young K Chou
6 Dec 2024
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by David A Oluwo, Lu Chen, Young K Chou
Investigators
FDA investigators tied to this site in the record.
Rachel C Harrington3 insp.
David A Oluwo2 insp.
Robert J Martin2 insp.
Simone E Pitts2 insp.
Alice S Tsao2 insp.
Toyin B Oladimeji2 insp.
Nebil A Oumer2 insp.
Brooke K Higgins2 insp.
Ernest Bizjak2 insp.
Lu Chen1 insp.
Young K Chou1 insp.
Bijoy Panicker1 insp.
Christina K Theodorou1 insp.
Erik W Koester1 insp.
Jonah S Ufferfilge1 insp.
Vivin George1 insp.
Rachael O Oyewole1 insp.
Kristina L Conroy1 insp.
Margaret M Doherty1 insp.
Marcellinus D Dordunoo1 insp.
Viviana Matta1 insp.
Shirshendu K Deb1 insp.
Kathleen M Jordan1 insp.
Yvins Dezan1 insp.
Junho Pak1 insp.
Edmund F Mrak1 insp.
Michael Shanks1 insp.
Alison N Stieg1 insp.
James M Mason1 insp.
Marcus A Ray1 insp.
Ko U Min1 insp.
Tonia F Bernard1 insp.
Nicholas A Violand1 insp.
Chaltu N Wakijra1 insp.
Zhongren Wu1 insp.
Jonathan W Chapman1 insp.
James M Simpson1 insp.
Chiang Syin1 insp.
Hector J Colon-Torres1 insp.
Sharon K Thoma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 25x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(c)(4) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | 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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmaceutics International, Inc.'s 16 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