Pharmathen International S.A.
Form 483 issued November 21, 2025 · Rodopi, Greece
- Inspection
- Nov 10 – Nov 21, 2025
- Investigators
- Justin A. Boyd· Khoa Nathan V. Tran
- Observations
- 1
- Pages
- 20
- FEI number
- 3009961173
In short: On November 21, 2025, FDA issued a Form 483 with 1 observation to Pharmathen International S.A. in Rodopi, Greece (FEI 3009961173) after an inspection that ran Nov 10 – Nov 21, 2025. The investigators were Justin A. Boyd and Khoa Nathan V. Tran. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmPharmathen International S.A. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmathen International S.A.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pharmathen International S.A.?
Justin A. Boyd and Khoa Nathan V. Tran are named on this Form 483, for the inspection of Nov 10 – Nov 21, 2025. Each investigator has a profile showing what they cite most.
When was Pharmathen International S.A. inspected by FDA?
The inspection ran Nov 10 – Nov 21, 2025, and the Form 483 is dated November 21, 2025.
How do I get the full Form 483 for Pharmathen International S.A.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.