Pharmathen International S.A.
Form 483 issued March 9, 2022 · Sapes, Greece
- Inspection
- Feb 28 – Mar 9, 2022
- Investigator
- Bijoy Panicker
- Observations
- 3
- Pages
- 3
- FEI number
- 3009961173
In short: On March 9, 2022, FDA issued a Form 483 with 3 observations to Pharmathen International S.A. in Sapes, Greece (FEI 3009961173) after an inspection that ran Feb 28 – Mar 9, 2022. The investigator was Bijoy Panicker. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Pharmathen International S.A.?
Bijoy Panicker is named on this Form 483, for the inspection of Feb 28 – Mar 9, 2022. Each investigator has a profile showing what they cite most.
When was Pharmathen International S.A. inspected by FDA?
The inspection ran Feb 28 – Mar 9, 2022, and the Form 483 is dated March 9, 2022.
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.