Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
6
Form 483s
5
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 21 Nov 2025 | Human Drugs | WL | View 483 → |
| 28 Feb 2022 – 9 Mar 2022 | Human Drugs | 483 | View 483 → |
| 6 Dec 2021 – 9 Dec 2021 | Human Drugs | Clean | |
| 2 Dec 2019 – 6 Dec 2019 | Human Drugs | 483 | View 483 → |
| 15 Apr 2019 – 19 Apr 2019 | Human Drugs | 483 | View 483 → |
| 19 Oct 2017 – 26 Oct 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran
21 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran
21 Nov 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Justin A Boyd, Khoa Nathan V Tran
21 Nov 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Justin A Boyd, Khoa Nathan V Tran
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Khoa Nathan V Tran1 insp.
Bijoy Panicker1 insp.
MRA NarulaA1 insp.
Sachinkumar V Patel1 insp.
Saleem A Akhtar1 insp.
Nicole E Knowlton1 insp.
Sena G Dissmeyer1 insp.
Junho Pak1 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 211.160(a) | 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 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | 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)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmathen International S.A.'s 5 Form 483s
Source PDFs 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