Overview
- 30 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-19.
At a glance
Inspections
30
Form 483s
13
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2025 – 19 Dec 2025 | Human Drugs | 483 | View 483 → |
| 30 Sep 2024 – 2 Oct 2024 | Human Drugs | Clean | |
| 6 Feb 2023 – 15 Feb 2023 | Human Drugs | 483 | View 483 → |
| 17 May 2022 – 25 May 2022 | Human Drugs | 483 | View 483 → |
| 12 Jul 2021 – 16 Jul 2021 | Human Drugs | Clean | |
| 18 Dec 2019 – 20 Dec 2019 | Human Drugs | Clean | |
| 24 Oct 2019 – 5 Nov 2019 | Human Drugs | 483 | View 483 → |
| 25 Feb 2019 – 1 Mar 2019 | Human Drugs | 483 | On file |
| 30 Jan 2017 – 9 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Nov 2016 – 7 Dec 2016 | Human Drugs | 483 | On file |
| 21 Jul 2015 – 10 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Aug 2014 – 12 Sep 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Taichun Qin, Claudia M Perez-Kasmarski, Thuy Tram L Nguyen, Ngozi G Offor
19 Dec 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Taichun Qin, Claudia M Perez-Kasmarski, Thuy Tram L Nguyen, Ngozi G Offor
19 Dec 2025
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Taichun Qin, Claudia M Perez-Kasmarski, Thuy Tram L Nguyen, Ngozi G Offor
19 Dec 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Taichun Qin, Claudia M Perez-Kasmarski, Thuy Tram L Nguyen, Ngozi G Offor
19 Dec 2025
21 CFR 211.48(a)
Potable water standards not met
Cited by Taichun Qin, Claudia M Perez-Kasmarski, Thuy Tram L Nguyen, Ngozi G Offor
Investigators
FDA investigators tied to this site in the record.
Marcus F Yambot5 insp.
Sonya L Karsik4 insp.
Carla J Lundi3 insp.
Taichun Qin2 insp.
Uttaniti Limchumroon2 insp.
Virgilio F Pacio2 insp.
Jinnie Kokiatkulkij2 insp.
Mark C Saale2 insp.
Claudia M Perez-Kasmarski1 insp.
Thuy Tram L Nguyen1 insp.
Ngozi G Offor1 insp.
Lan T Tran1 insp.
Joey V Quitania1 insp.
Lisa Shin1 insp.
Khoa Nathan V Tran1 insp.
Nicholas L Hunt1 insp.
Christopher R Czajka1 insp.
Bryan A Galvez1 insp.
Ashar P Parikh1 insp.
Sudipan Karmakar1 insp.
Stephanie A Slater1 insp.
William J Leonard1 insp.
Chelsea N Sealey1 insp.
Caryn M Mcnab1 insp.
Matthew J Johnson1 insp.
John A Gonzalez1 insp.
David Serrano1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.130(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(2)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind International Medication Systems Ltd.'s 13 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