Pharmathen International S.A.
FDA inspection history across 2 sites, 2022 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Sapes, Greece.
- 2022The longest 483 on file: 3 observations over 3 pages at Sapes, Greece.
- 2025–26One Form 483 and one warning letter, at Rodopi, Greece.
Cited most
Across all Pharmathen International observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Pharmathen International file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Rodopi, Greece
One Form 483 · 2025 · 1 observation
Latest: Form 483, Nov 21, 2025 →Sapes, Greece
One Form 483 · 2022 · 3 observations
Latest: Form 483, Mar 9, 2022 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-27 | Warning letter Warning letter | — | — | $99 |
| 2025-11-21 | 483 Form 483 | Rodopi, Greece | 1 | $99 |
| 2022-03-09 | 483 Form 483 | Sapes, Greece | 3 | $99 |
Investigators on these documents
FEI number 3009961173 · most recent document May 27, 2026
About Pharmathen International S.A.
How many FDA Form 483s has Pharmathen International S.A. received?
FDA Intel has 2 Form 483s on file for Pharmathen International S.A.; the most recent is dated Nov 21, 2025.
When was Pharmathen International S.A. last inspected by FDA?
The most recent FDA inspection document on file for Pharmathen International S.A. is a Form 483 dated Nov 21, 2025, for the site in Rodopi, Greece.
What did FDA cite at Pharmathen International S.A.?
The regulations cited most in the observations on file for Pharmathen International S.A. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.
Has Pharmathen International S.A. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmathen International S.A.; the most recent is dated May 27, 2026.